CHAWI: BAX 802 in CHA With Inhibitors

• Sponsor: Baxalta now part of Shire (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02895945
• Collaborator: Baxalta Innovations GmbH, now part of Shire (Industry)
• Enrollment: 8
• Locations: 24
• Arm: 1
• Actual Duration (Months): 49
• Patients Per Site: 0.3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of BAX 802 in males with congenital hemophilia A (CHA) with inhibitors who are undergoing major or minor elective surgical, dental, or other invasive procedures.

Condition or Disease	Intervention/Treatment	Phase
Hemophilia A	Biological: Antihemophilic Factor (Recombinant), Porcine Sequence (BAX 802)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Multicenter, Open-label Study of the Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (BAX 802) in Subjects With Congenital Hemophilia A With Factor VIII Inhibitors Undergoing Surgical or Other Invasive Procedures
• Actual Study Start Date: Dec 22, 2016
• Actual Primary Completion Date: Jan 22, 2021
• Actual Study Completion Date: Jan 22, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BAX 802 in Surgery Participants who are undergoing major or minor elective surgical, dental, or other invasive procedures.	Biological: Antihemophilic Factor (Recombinant), Porcine Sequence (BAX 802); In case of major surgery, FVIII target level is ≥80% for major surgeries/ procedures and ≥50% for minor surgeries/ procedures.; Other Names: BAX 802 recombinant porcine factor VIII Obizur rpFVIII

Outcome Measures

Primary Outcome Measures

1. Percentage of Surgeries With a "Good" or "Excellent" Response as Measured by the Global Hemostatic Efficacy Assessment (GHEA) Score [Day 1 up to discharge or Day 14 (whichever was earlier)]

   GHEA score consisted of 3 individual rating scales: (1) Intra-operative Efficacy Assessment Scale, (2) Post-operative Efficacy Assessment Scale, and (3) Overall Peri-operative Efficacy Assessment Scale. Scales 1 and 2 was performed by the operating surgeon on Day 1, and Scale 3 was performed by the investigator on Day 14. Each rating scale was based on 4 points scale ranging from: 3 (Excellent), 2 (Good), 1 (Fair), and 0 (None). Total score ranged from 0 to 9, where scores evaluated as: excellent (7 to 9), good (5 to 7), fair (3 to 4), and none (0 to 2). The scores of 3 individual ratings scales were added together to form a GHEA score. For a GHEA score of 7 to be rated "excellent" with no individual assessment scores less than (<) 2 and at least 1 assessment score equal to (=) 3; otherwise a score of 7 was rated "good". Percentage of Surgeries With a "Good" or "Excellent" response as measured by the GHEA score were reported.

Secondary Outcome Measures

1. Actual Blood Loss, Estimated Volume of Expected Average Blood Loss and Expected Maximum Blood Loss During Intra-operative, Post-operative and Peri-operative Period [Intra-operative: up to completion of surgery (Day 1), Post-operative: at 24 hours post-surgery, and Peri-operative: at discharge or Day 14 (whichever was earlier)]

   Prior to the surgery, the surgeon/investigator predicted and compared the estimated volume (in milliliter [mL]) of the expected average blood loss and expected maximum blood loss for the planned surgical intervention in a comparable healthy individual with similar demographic characteristics; for intraoperative, postoperative, and overall perioperative time periods. Intra-operative defined as period from start of surgery to completion of surgical procedure. Post-operative defined as period from completion of surgical procedure till 24 hours post-surgery. Peri-operative defined as period from start of surgical procedure till discharge or 14 days post surgery (whichever was earlier). Actual blood loss, estimated volume of expected average blood loss and expected maximum blood loss during each operative period was reported.

2. Ratio of Actual Blood Loss and Estimated Volume of Expected Average Blood Loss During Intra-operative, Post-operative and Peri-operative Period [Intra-operative: up to completion of surgery (Day 1), Post-operative: at 24 hours post-surgery, and Peri-operative: at discharge or Day 14 (whichever was earlier)]

   Prior to the surgery, the surgeon/investigator predicted and compared the estimated volume (mL) of the expected average blood loss and expected maximum blood loss for the planned surgical intervention in a comparable healthy individual with similar demographic characteristics; for intraoperative, postoperative, and overall perioperative time periods. Intra-operative defined as period from start of surgery to completion of surgical procedure. Post-operative defined as period from completion of surgical procedure till 24 hours post-surgery. Peri-operative defined as period from start of surgical procedure till discharge or 14 days post surgery (whichever was earlier). Ratio of actual blood loss and estimated volume of expected average blood loss during each operative period was reported.

3. Ratio of Actual Blood Loss and Expected Maximum Blood Loss During Intra-operative, Post-operative and Peri-operative Period [Intra-operative: up to completion of surgery (Day 1), Post-operative: at 24 hours post-surgery, and Peri-operative: at discharge or Day 14 (whichever was earlier)]

   Prior to the surgery, the surgeon/investigator predicted and compared the estimated volume (mL) of the expected average blood loss and expected maximum blood loss for the planned surgical intervention in a comparable healthy individual with similar demographic characteristics; for intraoperative, postoperative, and overall perioperative time periods. Intra-operative defined as period from start of surgery to completion of surgical procedure. Post-operative defined as period from completion of surgical procedure till 24 hours post-surgery. Peri-operative defined as period from start of surgical procedure till discharge or 14 days post surgery (whichever was earlier). Ratio of actual blood loss and expected maximum blood loss during each operative period was reported.

4. Percentage of Major Surgeries With Good or Excellent Hemostatic Score [Day 1 up to discharge or Day 14 (whichever was earlier)]

   Percentage of major surgeries with good or excellent hemostatic score was analyzed by GHEA score. It consisted of 3 individual ratings: (1) Intra-operative Efficacy Assessment Scale, (2) Post-operative Efficacy Assessment Scale, (3) Postoperative Efficacy Assessment Scale. Ratings 1 and 2 was performed by the operating surgeon on Day 1, and Rating 3 was performed by the investigator on Day 14. Each rating scale was based on 4 point scale ranging from: 3 (Excellent), 2 (Good), 1 (Fair), and 0 (None). The scores of each of the 3 individual ratings scales, was added together to form a GHEA score. Total score ranged from 0 to 9 where scores evaluated as excellent (7 to 9), good (5 to 7), fair (3 to 4), and none (0 to 2). Hemostatic efficacy success was defined as "excellent" or "good "outcome for >=70% of hemostatic efficacy assessments. Percentage of major surgeries with good or excellent hemostatic score were reported.

5. Average Daily Weight-adjusted Dose of BAX 802 Per Participant During Pre-operative, Intra-operative and Post-operative Period [Pre-operative: before surgery, Intra-operative: up to completion of surgery (Day 1), Post-operative: from completion of surgical procedure till discharge or 14 days post surgery (whichever was earlier)]

   Body-weight adjusted dose equals to amount infused/body-weight (kilogram [kg]), where amount infused as amount of drug infused (International Units [IU]) and body-weight as the last available body-weight (kg) prior to the infusion. Pre-operative defined as period prior to surgery. Intra-operative defined as period from start of surgery to completion of surgical procedure. Post-operative defined as period from completion of surgical procedure till discharge or 14 days post surgery (whichever was earlier). Average daily weight-adjusted dose of BAX 802 per participant during each operative period was reported.

6. Total Weight-adjusted Dose of BAX 802 Per Participant During Pre-operative, Intra-operative and Post-operative Period [Pre-operative: before surgery, Intra-operative: up to completion of surgery (Day 1), Post-operative: from completion of surgical procedure till discharge or 14 days post surgery (whichever was earlier)]

   Body-weight adjusted dose equals to amount infused/body-weight (kg), where amount infused as amount of drug infused (IU) and body-weight as the last available body-weight (kg) prior to the infusion. Pre-operative defined as period prior to surgery. Intra-operative defined as period from start of surgery to completion of surgical procedure. Post-operative defined as period from completion of surgical procedure till discharge or 14 days post surgery (whichever was earlier). Total weight-adjusted dose of BAX 802 per participant during each operative period was reported.

7. Volume of Blood Products Transfused [From initiation of the surgery up to discharge or Day 14 (whichever came earlier)]

   The volume (in mL) of blood products transfused from initiation of the intervention to discharge or Day 14 (whichever came earlier) was reported.

8. Number of Participants With De Novo Inhibitors [Baseline up end of study (EOS) (up to 44 months)]

   De novo inhibitor was defined as a post-baseline inhibitor titer to FVIII (hFVIII or porcine factor VIII [pFVIII])of >=0.6 Bethesda units per milliliter (BU/mL) given a baseline of <0.6 BU/mL. Number of participants with de novo inhibitors were reported.

9. Number of Participants With Anamnestic Reactions [Baseline up to EOS (up to 44 months)]

   An anamnestic reaction was defined as an increase from a measurable baseline (>0.6 BU/mL) in the inhibitor titer to FVIII (human or porcine) of >=10 BU/mL. Number of participants with anamnestic reactions were reported.

10. Mean Change From Baseline up to EOS in Inhibitory and Binding Antibodies to pFVIII [Baseline up to EOS (up to 44 months)]

    The assessment of inhibitory antibodies (immunoglobulin G [IgG] and immunoglobulin M [IgM]) to pFVIII was determined using Bethesda assay, and assessment of binding antibodies (IgG and IgM) to pFVIII was determined using validated enzyme-linked immunosorbent assays (ELISAs). Mean change from baseline in inhibitory and binding antibodies to pFVIII was reported.

11. Mean Change From Baseline up to EOS in Inhibitory and Binding Antibodies to hFVIII [Baseline up to EOS (up to 44 months)]

    The assessment of inhibitory antibodies (IgG and IgM) to hFVIII was determined using Bethesda assay, and assessment of binding antibodies (IgG and IgM) to hFVIII was determined using ELISA. Mean change from baseline in inhibitory and binding antibodies to hFVIII was reported.

12. Number of Participants With Clinically Significant Change From Baseline in Binding Antibodies to Baby Hamster Kidney (BHK) Proteins [Baseline up to EOS (up to 44 months)]

    The assessment of binding antibodies to BHK proteins was determined using ELISA. Clinical significance was judged by the investigator. Number of participants with clinically significant change from baseline in binding antibodies to BHK proteins were reported.

13. Number of Participants With Thromboembolic Events [Baseline up to EOS (up to 44 months)]

    Thromboembolism defined as formation in a blood vessel of a clot (thrombus) that breaks loose and carried by the blood stream to plug another vessel. Number of participants with thromboembolic events was reported.

14. Number of Participants With Severe Allergic Reactions [Baseline up to EOS (up to 44 months)]

    Number of participants with severe allergic reaction (example: anaphylaxis) after administration of study drug were reported.

15. Number of Participants With Investigational Product (IP) Related Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs [Baseline up to EOS (up to 44 months)]

    An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Serious AE was any untoward medical occurrence (whether considered to be related to study assigned treatment or not) that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital abnormality/birth defect, or was an important medical event. TEAEs was defined as any adverse events (classified by preferred term) that had a start date on or after the first dose of study treatment or that had a start date before the date of first dose of study treatment, but increased in severity after the first dose of study treatment. TEAEs included both serious and non-serious TEAEs.

16. Number of Participants With Clinically Significant Change From Baseline in Vital Sign [Baseline up to EOS (up to 44 months)]

    Vital sign parameters included: temperature, pulse rate, respiration rate, systolic and diastolic blood pressure. Any changes in vital signs which were deemed clinically significant was judged by the investigator. Number of participants with clinically significant change from baseline in vital signs were reported.

17. Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values [Baseline up to EOS (up to 44 months)]

    Clinical laboratory assessment included hematology and clinical chemistry. Any changes in clinical laboratory results which were deemed clinically significant was judged by the investigator. Number of participants with clinical significant change from baseline in clinical laboratory values were reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 75 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria

1. Participant requires a major or minor elective surgical, dental or other invasive procedure

2. Participant is male and ≥ 12 to ≤ 75 years old at the time of screening

3. Participant has provided signed informed consent (and assent for adolescent participants, as applicable) in accordance with local regulatory requirements

4. Participant has severe (factor VIII (FVIII) level < 1%) or moderately severe (FVIII level ≤ 2%) congenital hemophilia A (CHA) with inhibitors to human factor VIII (hFVIII) of ≥ 0.6 Bethesda units (BU), as tested at screening at the central laboratory

5. Participant is not currently receiving or has recently received (< 30 days) immune tolerance induction (ITI) therapy

6. Participant has a Karnofsky performance score of ≥ 60 at screening

7. Participant is human immunodeficiency virus negative (HIV-); or HIV+ with stable disease and CD4+ count ≥ 200 cells/mm^3 at screening

8. Participant is hepatitis C virus negative (HCV-) by antibody or polymerase chain reaction (PCR) testing; or HCV+ with chronic stable hepatitis disease. Positive serologies will be confirmed by PCR testing.

9. Participant is willing and able to comply with the requirements of the protocol.

Exclusion Criteria

1. The participant requires emergency surgery

2. Severe chronic liver dysfunction or disease (e.g., ≥ 5 × upper limit of normal [ULN] alanine aminotransferase [ALT], as confirmed by central laboratory at screening or a documented prothrombin time/international normalized ratio [PT/INR] > 1.5)

3. Clinically symptomatic renal disease (serum creatinine > 2.0 mg/dL), as confirmed by central laboratory at screening

4. Anti-porcine factor VIII (pFVIII) inhibitor > 10 BU prior to surgery

5. Platelet count < 100,000/μL at screening

6. Participant has another active coagulation disorder, other than hemophilia A, as per the medical history

7. Planned use of α-interferon with or without ribavirin for HCV infected patients or planned use of a protease inhibitor for HIV infected patients. Patients currently taking any of these medications for ≥ 30 days are eligible

8. Known hypersensitivity to recombinant porcine factor VIII (rpFVIII), or hamster or murine proteins

9. Participant has an ongoing or recent (within 3 months of screening) thrombo-embolic disease, fibrinolysis or disseminated intravascular coagulation (DIC)

10. Participant has been exposed to an IP within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an investigational product (IP) or investigational device during the course of this study

11. Participant is unable to tolerate quantity of blood to be drawn for protocol procedures

12. Participant is a family member or employee of the Investigator.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bleeding and Clotting Disorders Institute	Peoria	Illinois	United States	61615
2	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina	United States	27157
3	Case Western Reserve University	Cleveland	Ohio	United States	44106-7284
4	UMHAT 'Tsaritsa Yoanna - ISUL', EAD	Sofia		Bulgaria	1527
5	UMHATEM 'N.I. Pirogov', EAD	Sofia		Bulgaria	1606
6	Hopital Maisonneuve-Rosemont d/b/a CIUSSS de l'Est-de-l'Île-de-Montréal	Montréal	Quebec	Canada	H1T 2M4
7	Universitaetsklinikum Bonn AoeR	Bonn		Germany	53127
8	Zentrum für Hämostaseologie, Universitätsklinikum Leipzig AöR	Leipzig		Germany	04103
9	Presidio Ospedaliero di Castelfranco Veneto	Castelfranco Veneto	Treviso	Italy	31033
10	Azienda Ospedaliera Universitaria Careggi	Firenze		Italy	50134
11	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milano		Italy	20122
12	Azienda Ospedaliera di Padova	Padova		Italy	35128
13	UMC Utrecht	Utrecht		Netherlands	3584 CX
14	Oslo Universitetssykehus - Rikshospitalet	Oslo		Norway	0372
15	Instytut Hematologii i Transfuzjologii-1-1Y7-1347	Warszawa		Poland	02-776
16	FSBI of Science "Kirov Scientific and Research Institute of Hematology and Blood Transfusion of FMBA.	Kirov		Russian Federation	610027
17	Bleeding Disorders Unit and Clinical Haematology Service at Charlotte Maxeke JHB Academic Hospital	Johannesburg		South Africa	2193
18	Hospital Universitari i Politecnic La Fe	Valencia	Comunidad Valenciana	Spain	46026
19	Complejo Hospitalario Universitario A Coruña	La Coruña		Spain	15006
20	Hospital Universitario La Paz	Madrid		Spain	28046
21	Ankara University Medical Faculty	Ankara		Turkey	6590
22	Ege University Medical Faculty	Izmir		Turkey	35040
23	Ege University Medical Faculty	Izmir		Turkey	35100
24	Kocaeli University Medical Faculty	Kocaeli		Turkey	41300

Sponsors and Collaborators

• Baxalta now part of Shire
• Baxalta Innovations GmbH, now part of Shire

Investigators

• Study Director: Study Director, Shire

Study Documents (Full-Text)

• Study Protocol - Dec 14, 2017
• Statistical Analysis Plan - Apr 20, 2021

More Information

Additional Information:

• To obtain more information on the study, click here/on this link

Publications

None provided.

• Responsible Party: Baxalta now part of Shire
• ClinicalTrials.gov Identifier: NCT02895945
• Other Study ID Numbers: 241502; 2015-005521-39
• First Posted: Sep 12, 2016
• Last Update Posted: Oct 20, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hemophilia A; Factor VIII

Study Results

Participant Flow

Recruitment Details	This study was conducted at 5 sites in Italy, Netherlands, Poland, Germany and Turkey. Study was initiated on 22 December 2016 and terminated on 22 January 2021.
Pre-assignment Detail	A total of 8 participants planned for Major Surgeries and Minor Surgeries received recombinant porcine factor VIII (rpFVIII) (BAX 802).

Arm/Group Title	Major Surgeries	Minor Surgeries
Arm/Group Description	Male participants with congenital hemophilia A (CHA) with inhibitors to human factor VIII (hFVIII) undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target factor VIII (FVIII) level of greater than or equal to (>=) 80 percent (%) approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
Period Title: Overall Study
STARTED	7	1
SAS	7	1
FAS	7	0
COMPLETED	5	0
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Major Surgeries	Minor Surgeries	Total
Arm/Group Description	Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Total of all reporting groups
Overall Participants	7	1	8
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.9 (14.39)	58.0	38.6 (15.45)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	7 100%	1 100%	8 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	7 100%	1 100%	8 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 14.3%	0 0%	1 12.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	6 85.7%	1 100%	7 87.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Surgeries With a "Good" or "Excellent" Response as Measured by the Global Hemostatic Efficacy Assessment (GHEA) Score
Description	GHEA score consisted of 3 individual rating scales: (1) Intra-operative Efficacy Assessment Scale, (2) Post-operative Efficacy Assessment Scale, and (3) Overall Peri-operative Efficacy Assessment Scale. Scales 1 and 2 was performed by the operating surgeon on Day 1, and Scale 3 was performed by the investigator on Day 14. Each rating scale was based on 4 points scale ranging from: 3 (Excellent), 2 (Good), 1 (Fair), and 0 (None). Total score ranged from 0 to 9, where scores evaluated as: excellent (7 to 9), good (5 to 7), fair (3 to 4), and none (0 to 2). The scores of 3 individual ratings scales were added together to form a GHEA score. For a GHEA score of 7 to be rated "excellent" with no individual assessment scores less than (<) 2 and at least 1 assessment score equal to (=) 3; otherwise a score of 7 was rated "good". Percentage of Surgeries With a "Good" or "Excellent" response as measured by the GHEA score were reported.
Time Frame	Day 1 up to discharge or Day 14 (whichever was earlier)

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) comprised of all participants with at least one available hemostatic assessment.

Arm/Group Title	Major Surgeries	Minor Surgeries
Arm/Group Description	Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
Measure Participants	7	0
Measure surgeries	7	0
GHEA rating: Good	14.3
GHEA rating: Excellent	71.4

2. Secondary Outcome

Title	Actual Blood Loss, Estimated Volume of Expected Average Blood Loss and Expected Maximum Blood Loss During Intra-operative, Post-operative and Peri-operative Period
Description	Prior to the surgery, the surgeon/investigator predicted and compared the estimated volume (in milliliter [mL]) of the expected average blood loss and expected maximum blood loss for the planned surgical intervention in a comparable healthy individual with similar demographic characteristics; for intraoperative, postoperative, and overall perioperative time periods. Intra-operative defined as period from start of surgery to completion of surgical procedure. Post-operative defined as period from completion of surgical procedure till 24 hours post-surgery. Peri-operative defined as period from start of surgical procedure till discharge or 14 days post surgery (whichever was earlier). Actual blood loss, estimated volume of expected average blood loss and expected maximum blood loss during each operative period was reported.
Time Frame	Intra-operative: up to completion of surgery (Day 1), Post-operative: at 24 hours post-surgery, and Peri-operative: at discharge or Day 14 (whichever was earlier)

Outcome Measure Data

Analysis Population Description

FAS comprised of all participants with at least one available hemostatic assessment. Here "number analyzed" were participants who were evaluable for the outcome measure at given categories.

Arm/Group Title	Major Surgeries	Minor Surgeries
Arm/Group Description	Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
Measure Participants	7	0
Measure surgeries	7	0
Intra-operative Period: Actual Blood Loss	141.1 (188.69)
Intra-operative Period: Expected Average Blood Loss	221.7 (286.76)
Intra-operative Period: Expected Maximum Blood Loss	414.7 (546.37)
Post-operative Period: Actual Blood Loss	31.0 (66.56)
Post-operative Period: Expected Average Blood Loss	171.4 (276.17)
Post-operative Period: Expected Maximum Blood Loss	378.0 (570.94)
Peri-operative Period: Actual Blood Loss	164.1 (215.15)
Peri-operative Period: Expected Average Blood Loss	465.0 (744.85)
Peri-operative Period: Expected Maximum Blood Loss	842.9 (1310.01)

3. Secondary Outcome

Title	Ratio of Actual Blood Loss and Estimated Volume of Expected Average Blood Loss During Intra-operative, Post-operative and Peri-operative Period
Description	Prior to the surgery, the surgeon/investigator predicted and compared the estimated volume (mL) of the expected average blood loss and expected maximum blood loss for the planned surgical intervention in a comparable healthy individual with similar demographic characteristics; for intraoperative, postoperative, and overall perioperative time periods. Intra-operative defined as period from start of surgery to completion of surgical procedure. Post-operative defined as period from completion of surgical procedure till 24 hours post-surgery. Peri-operative defined as period from start of surgical procedure till discharge or 14 days post surgery (whichever was earlier). Ratio of actual blood loss and estimated volume of expected average blood loss during each operative period was reported.
Time Frame	Intra-operative: up to completion of surgery (Day 1), Post-operative: at 24 hours post-surgery, and Peri-operative: at discharge or Day 14 (whichever was earlier)

Outcome Measure Data

Analysis Population Description

FAS comprised of all participants with at least one available hemostatic assessment. Here "number analyzed" were participants who were evaluable for the outcome measure at given categories.

Arm/Group Title	Major Surgeries	Minor Surgeries
Arm/Group Description	Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
Measure Participants	7	0
Measure surgeries	7	0
Intra-operative Period	0.970 (0.9486)
Post-operative Period	0.150 (0.2236)
Peri-operative Period	0.545 (0.3448)

4. Secondary Outcome

Title	Ratio of Actual Blood Loss and Expected Maximum Blood Loss During Intra-operative, Post-operative and Peri-operative Period
Description	Prior to the surgery, the surgeon/investigator predicted and compared the estimated volume (mL) of the expected average blood loss and expected maximum blood loss for the planned surgical intervention in a comparable healthy individual with similar demographic characteristics; for intraoperative, postoperative, and overall perioperative time periods. Intra-operative defined as period from start of surgery to completion of surgical procedure. Post-operative defined as period from completion of surgical procedure till 24 hours post-surgery. Peri-operative defined as period from start of surgical procedure till discharge or 14 days post surgery (whichever was earlier). Ratio of actual blood loss and expected maximum blood loss during each operative period was reported.
Time Frame	Intra-operative: up to completion of surgery (Day 1), Post-operative: at 24 hours post-surgery, and Peri-operative: at discharge or Day 14 (whichever was earlier)

Outcome Measure Data

Analysis Population Description

FAS comprised of all participants with at least one available hemostatic assessment. Here "number analyzed" were participants who were evaluable for the outcome measure at given categories.

Arm/Group Title	Major Surgeries	Minor Surgeries
Arm/Group Description	Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
Measure Participants	7	0
Measure surgeries	7	0
Intra-operative Period	0.555 (0.6517)
Post-operative Period	0.058 (0.0846)
Peri-operative Period	0.306 (0.1962)

5. Secondary Outcome

Title	Percentage of Major Surgeries With Good or Excellent Hemostatic Score
Description	Percentage of major surgeries with good or excellent hemostatic score was analyzed by GHEA score. It consisted of 3 individual ratings: (1) Intra-operative Efficacy Assessment Scale, (2) Post-operative Efficacy Assessment Scale, (3) Postoperative Efficacy Assessment Scale. Ratings 1 and 2 was performed by the operating surgeon on Day 1, and Rating 3 was performed by the investigator on Day 14. Each rating scale was based on 4 point scale ranging from: 3 (Excellent), 2 (Good), 1 (Fair), and 0 (None). The scores of each of the 3 individual ratings scales, was added together to form a GHEA score. Total score ranged from 0 to 9 where scores evaluated as excellent (7 to 9), good (5 to 7), fair (3 to 4), and none (0 to 2). Hemostatic efficacy success was defined as "excellent" or "good "outcome for >=70% of hemostatic efficacy assessments. Percentage of major surgeries with good or excellent hemostatic score were reported.
Time Frame	Day 1 up to discharge or Day 14 (whichever was earlier)

Outcome Measure Data

Analysis Population Description

FAS comprised of all participants with at least one available hemostatic assessment. As planned, this outcome measure was only analyzed for major surgeries. There were 7 participants analyzed for major surgeries and all the 7 participants underwent 7 surgeries.

Arm/Group Title	Major Surgeries
Arm/Group Description	Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
Measure Participants	7
Measure surgeries	7
Number (95% Confidence Interval) [percentage of surgeries]	85.7

6. Secondary Outcome

Title	Average Daily Weight-adjusted Dose of BAX 802 Per Participant During Pre-operative, Intra-operative and Post-operative Period
Description	Body-weight adjusted dose equals to amount infused/body-weight (kilogram [kg]), where amount infused as amount of drug infused (International Units [IU]) and body-weight as the last available body-weight (kg) prior to the infusion. Pre-operative defined as period prior to surgery. Intra-operative defined as period from start of surgery to completion of surgical procedure. Post-operative defined as period from completion of surgical procedure till discharge or 14 days post surgery (whichever was earlier). Average daily weight-adjusted dose of BAX 802 per participant during each operative period was reported.
Time Frame	Pre-operative: before surgery, Intra-operative: up to completion of surgery (Day 1), Post-operative: from completion of surgical procedure till discharge or 14 days post surgery (whichever was earlier)

Outcome Measure Data

Analysis Population Description

SAS comprised of all participants who received any amount of BAX 802. Here "number analyzed" were participants who were evaluable for the outcome measure at given categories.

Arm/Group Title	Major Surgeries	Minor Surgeries
Arm/Group Description	Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
Measure Participants	7	1
Pre-operative	162.471 (125.7051)	208.779
Intra-operative	76.083 (35.1339)
Post-operative	43.549 (56.0039)

7. Secondary Outcome

Title	Total Weight-adjusted Dose of BAX 802 Per Participant During Pre-operative, Intra-operative and Post-operative Period
Description	Body-weight adjusted dose equals to amount infused/body-weight (kg), where amount infused as amount of drug infused (IU) and body-weight as the last available body-weight (kg) prior to the infusion. Pre-operative defined as period prior to surgery. Intra-operative defined as period from start of surgery to completion of surgical procedure. Post-operative defined as period from completion of surgical procedure till discharge or 14 days post surgery (whichever was earlier). Total weight-adjusted dose of BAX 802 per participant during each operative period was reported.
Time Frame	Pre-operative: before surgery, Intra-operative: up to completion of surgery (Day 1), Post-operative: from completion of surgical procedure till discharge or 14 days post surgery (whichever was earlier)

Outcome Measure Data

Analysis Population Description

SAS comprised of all participants who received any amount of BAX 802. Here "number analyzed" were participants who were evaluable for the outcome measure at given categories.

Arm/Group Title	Major Surgeries	Minor Surgeries
Arm/Group Description	Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
Measure Participants	7	1
Pre-operative	162.471 (125.7051)	208.779
Intra-operative	76.083 (35.1339)
Post-operative	625.520 (399.4913)

8. Secondary Outcome

Title	Volume of Blood Products Transfused
Description	The volume (in mL) of blood products transfused from initiation of the intervention to discharge or Day 14 (whichever came earlier) was reported.
Time Frame	From initiation of the surgery up to discharge or Day 14 (whichever came earlier)

Outcome Measure Data

Analysis Population Description

FAS comprised of all participants with at least one available hemostatic assessment. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure.

Arm/Group Title	Major Surgeries	Minor Surgeries
Arm/Group Description	Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
Measure Participants	2	0
Mean (Standard Deviation) [mL]	950.0 (70.71)

9. Secondary Outcome

Title	Number of Participants With De Novo Inhibitors
Description	De novo inhibitor was defined as a post-baseline inhibitor titer to FVIII (hFVIII or porcine factor VIII [pFVIII])of >=0.6 Bethesda units per milliliter (BU/mL) given a baseline of <0.6 BU/mL. Number of participants with de novo inhibitors were reported.
Time Frame	Baseline up end of study (EOS) (up to 44 months)

Outcome Measure Data

Analysis Population Description

SAS comprised of all participants who received any amount of BAX 802.

Arm/Group Title	Major Surgeries	Minor Surgeries
Arm/Group Description	Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
Measure Participants	7	1
hFVIII	0 0%	0 0%
pFVIII	3 42.9%	0 0%

10. Secondary Outcome

Title	Number of Participants With Anamnestic Reactions
Description	An anamnestic reaction was defined as an increase from a measurable baseline (>0.6 BU/mL) in the inhibitor titer to FVIII (human or porcine) of >=10 BU/mL. Number of participants with anamnestic reactions were reported.
Time Frame	Baseline up to EOS (up to 44 months)

Outcome Measure Data

Analysis Population Description

SAS comprised of all participants who received any amount of BAX 802.

Arm/Group Title	Major Surgeries	Minor Surgeries
Arm/Group Description	Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
Measure Participants	7	1
hFVIII	5 71.4%	0 0%
pFVIII	3 42.9%	0 0%

11. Secondary Outcome

Title	Mean Change From Baseline up to EOS in Inhibitory and Binding Antibodies to pFVIII
Description	The assessment of inhibitory antibodies (immunoglobulin G [IgG] and immunoglobulin M [IgM]) to pFVIII was determined using Bethesda assay, and assessment of binding antibodies (IgG and IgM) to pFVIII was determined using validated enzyme-linked immunosorbent assays (ELISAs). Mean change from baseline in inhibitory and binding antibodies to pFVIII was reported.
Time Frame	Baseline up to EOS (up to 44 months)

Outcome Measure Data

Analysis Population Description

SAS comprised of all participants who received any amount of BAX 802. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure.

Arm/Group Title	Major Surgeries	Minor Surgeries
Arm/Group Description	Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
Measure Participants	6	1
Mean (Standard Deviation) [BU/mL]	111.15 (149.072)	-0.20

12. Secondary Outcome

Title	Mean Change From Baseline up to EOS in Inhibitory and Binding Antibodies to hFVIII
Description	The assessment of inhibitory antibodies (IgG and IgM) to hFVIII was determined using Bethesda assay, and assessment of binding antibodies (IgG and IgM) to hFVIII was determined using ELISA. Mean change from baseline in inhibitory and binding antibodies to hFVIII was reported.
Time Frame	Baseline up to EOS (up to 44 months)

Outcome Measure Data

Analysis Population Description

SAS comprised of all participants who received any amount of BAX 802. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure.

Arm/Group Title	Major Surgeries	Minor Surgeries
Arm/Group Description	Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
Measure Participants	6	1
Mean (Standard Deviation) [BU/mL]	198.67 (317.254)	-0.20

13. Secondary Outcome

Title	Number of Participants With Clinically Significant Change From Baseline in Binding Antibodies to Baby Hamster Kidney (BHK) Proteins
Description	The assessment of binding antibodies to BHK proteins was determined using ELISA. Clinical significance was judged by the investigator. Number of participants with clinically significant change from baseline in binding antibodies to BHK proteins were reported.
Time Frame	Baseline up to EOS (up to 44 months)

Outcome Measure Data

Analysis Population Description

SAS comprised of all participants who received any amount of BAX 802.

Arm/Group Title	Major Surgeries	Minor Surgeries
Arm/Group Description	Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
Measure Participants	7	1
Count of Participants [Participants]	0 0%	0 0%

14. Secondary Outcome

Title	Number of Participants With Thromboembolic Events
Description	Thromboembolism defined as formation in a blood vessel of a clot (thrombus) that breaks loose and carried by the blood stream to plug another vessel. Number of participants with thromboembolic events was reported.
Time Frame	Baseline up to EOS (up to 44 months)

Outcome Measure Data

Analysis Population Description

SAS comprised of all participants who received any amount of BAX 802.

Arm/Group Title	Major Surgeries	Minor Surgeries
Arm/Group Description	Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
Measure Participants	7	1
Count of Participants [Participants]	0 0%	0 0%

15. Secondary Outcome

Title	Number of Participants With Severe Allergic Reactions
Description	Number of participants with severe allergic reaction (example: anaphylaxis) after administration of study drug were reported.
Time Frame	Baseline up to EOS (up to 44 months)

Outcome Measure Data

Analysis Population Description

SAS comprised of all participants who received any amount of BAX 802.

Arm/Group Title	Major Surgeries	Minor Surgeries
Arm/Group Description	Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
Measure Participants	7	1
Count of Participants [Participants]	0 0%	0 0%

16. Secondary Outcome

Title	Number of Participants With Investigational Product (IP) Related Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Description	An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Serious AE was any untoward medical occurrence (whether considered to be related to study assigned treatment or not) that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital abnormality/birth defect, or was an important medical event. TEAEs was defined as any adverse events (classified by preferred term) that had a start date on or after the first dose of study treatment or that had a start date before the date of first dose of study treatment, but increased in severity after the first dose of study treatment. TEAEs included both serious and non-serious TEAEs.
Time Frame	Baseline up to EOS (up to 44 months)

Outcome Measure Data

Analysis Population Description

SAS comprised of all participants who received any amount of BAX 802.

Arm/Group Title	Major Surgeries	Minor Surgeries
Arm/Group Description	Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
Measure Participants	7	1
IP related TEAEs	4 57.1%	0 0%
IP related serious TEAEs	4 57.1%	0 0%

17. Secondary Outcome

Title	Number of Participants With Clinically Significant Change From Baseline in Vital Sign
Description	Vital sign parameters included: temperature, pulse rate, respiration rate, systolic and diastolic blood pressure. Any changes in vital signs which were deemed clinically significant was judged by the investigator. Number of participants with clinically significant change from baseline in vital signs were reported.
Time Frame	Baseline up to EOS (up to 44 months)

Outcome Measure Data

Analysis Population Description

SAS comprised of all participants who received any amount of BAX 802.

Arm/Group Title	Major Surgeries	Minor Surgeries
Arm/Group Description	Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
Measure Participants	7	1
Count of Participants [Participants]	0 0%	0 0%

18. Secondary Outcome

Title	Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values
Description	Clinical laboratory assessment included hematology and clinical chemistry. Any changes in clinical laboratory results which were deemed clinically significant was judged by the investigator. Number of participants with clinical significant change from baseline in clinical laboratory values were reported.
Time Frame	Baseline up to EOS (up to 44 months)

Outcome Measure Data

Analysis Population Description

SAS comprised of all participants who received any amount of BAX 802.

Arm/Group Title	Major Surgeries	Minor Surgeries
Arm/Group Description	Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
Measure Participants	7	1
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	Baseline up to EOS (up to 44 months)
Arm/Group Title	Major Surgeries		Minor Surgeries
Arm/Group Description	Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.		Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of >=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
All Cause Mortality
	Major Surgeries		Minor Surgeries
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/1 (0%)
Serious Adverse Events
	Major Surgeries		Minor Surgeries
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/7 (85.7%)		0/1 (0%)
Immune system disorders
Anamnestic reaction	1/7 (14.3%)	1	0/1 (0%)	0
Infections and infestations
Bacterial infection	1/7 (14.3%)	1	0/1 (0%)	0
Investigations
Anti factor VIII antibody increased	2/7 (28.6%)	2	0/1 (0%)	0
Anti factor VIII antibody positive	3/7 (42.9%)	3	0/1 (0%)	0
Musculoskeletal and connective tissue disorders
Haemarthrosis	1/7 (14.3%)	1	0/1 (0%)	0
Other (Not Including Serious) Adverse Events
	Major Surgeries		Minor Surgeries
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/7 (42.9%)		0/1 (0%)
Blood and lymphatic system disorders
Anaemia	1/7 (14.3%)	1	0/1 (0%)	0
Cardiac disorders
Tachycardia	1/7 (14.3%)	1	0/1 (0%)	0
General disorders
Pyrexia	1/7 (14.3%)	1	0/1 (0%)	0
Infections and infestations
Oral herpes	1/7 (14.3%)	1	0/1 (0%)	0
Injury, poisoning and procedural complications
Anaemia postoperative	1/7 (14.3%)	3	0/1 (0%)	0
Musculoskeletal and connective tissue disorders
Pain in extremity	1/7 (14.3%)	1	0/1 (0%)	0
Skin and subcutaneous tissue disorders
Pruritus	1/7 (14.3%)	1	0/1 (0%)	0
Skin irritation	1/7 (14.3%)	1	0/1 (0%)	0
Vascular disorders
Hypertension	1/7 (14.3%)	1	0/1 (0%)	0

Limitations/Caveats

Study was discontinued as Takeda determined that the benefit/risk profile did not support continuation of the surgery study for this specific Congenital Hemophilia A with Inhibitors participant population.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.