CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES, INCLUDING (BUT NOT LIMITED TO) THOSE WHO HAVE COMPLETED THE SCGAM-01 TRIAL
Sponsor
Octapharma (Industry)
Overall Status
Completed
CT.gov ID
NCT03907241
Collaborator
(none)
27
7
1
42.2
3.9
0.1
Study Details
Study Description
Brief Summary
Summary for SCGAM-03: Clinical phase III study to monitor the safety, tolerability and efficacy of subcutaneous human immunoglobulin (Octanorm) in patients with primary immunodeficiency diseases who have completed the SCGAM-01 trial.
Summary for SCGAM-03 in Canada: Clinical phase III study to monitor the safety, tolerability and efficacy of subcutaneous human immunoglobulin (octanorm) in patients with primary immunodeficiency diseases, including (but not limited to) those who have completed the SCGAM-01 trial
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
27 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Title for SCGAM-03: CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES WHO HAVE COMPLETED THE SCGAM-01 TRIAL Title for SCGAM-03 in Canada: CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES, INCLUDING (BUT NOT LIMITED TO) THOSE WHO HAVE COMPLETED THE SCGAM-01 TRIAL
Actual Study Start Date
:
Mar 1, 2016
Actual Primary Completion Date
:
Sep 5, 2019
Actual Study Completion Date
:
Sep 5, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Octanorm 16.5% octanorm 16.5%, human normal immunoglobulin for subcutaneous (SC) administration. |
Drug: Octanorm 16.5%
Human normal immunoglobulin
|
Outcome Measures
Primary Outcome Measures
- Occurrence of All Treatment-emergent Adverse Events (TEAEs) [From study start to end, up to 3.5 years]
Number of TEAEs
- Occurrence of Temporally Associated TEAEs [From study start to end, up to 3.5 years]
- Number of Temporally Associated TEAEs by Infusion Rate [From study start to end, up to 3.5 years]
Number of temporally associated TEAEs by infusion rate. Only includes systemic TEAEs without infections and without infusion site reactions
- Local Injection-site Reactions [From study start to end, up to 3.5 years]
- Blood Pressure [From study start to end, up to 3.5 years]
Systolic and diastolic.
- Body Temperature [From study start to end, up to 3.5 years]
- Respiratory Rate [From study start to end, up to 3.5 years]
- Sodium [From study start to end, up to 3.5 years]
Changes in sodium levels from baseline to end of study
- Potassium [From study start to end, up to 3.5 years]
Changes in potassium levels from baseline to end of study
- Blood Glucose [From study start to end, up to 3.5 years]
Changes in blood glucose from baseline to end of study
- ALAT [From study start to end, up to 3.5 years]
Changes in ALAT (alanine transaminase) from baseline to end of study
- ASAT [From study start to end, up to 3.5 years]
Changes in ASAT (aspartate aminotransferase) from baseline to end of study
- LDH [From study start to end, up to 3.5 years]
Changes in LDH (lactate dehydrogenase) from baseline to end of study
- Total Bilirubin [From study start to end, up to 3.5 years]
Changes in total bilirubin from baseline to end of study
- Blood Urea Nitrogen [From study start to end, up to 3.5 years]
Changes in blood urea nitrogen from baseline to end of study
- Creatinine [From study start to end, up to 3.5 years]
Changes in creatinine from baseline to end of study
- Urine pH [From study start to end, up to 3.5 years]
Changes in urine pH from baseline to end of study
- Number of Participants With a Change in Urine Glucose [From study start to end, up to 3.5 years]
Number of Participants with a Change in Urine Glucose
- Number of Participants With a Change in Urine Ketones [From study start to end, up to 3.5 years]
Number of Participants With a Change in Urine Ketones at baseline and end of study
- Number of Participants With a Change in Urine Leukocytes [From study start to end, up to 3.5 years]
Number of participants with a change in urine leukocytes at baseline and end of study
- Number of Participants With a Change in Urine Hemoglobin [From study start to end, up to 3.5 years]
Number of participants with a change in urine hemoglobin at baseline and end of study
- Complete Red Blood Cell Count [From study start to end, up to 3.5 years]
Changes in complete red blood cell count from baseline to end of study
- Haematocrit [From study start to end, up to 3.5 years]
Changes in haematocrit from baseline to end of study
- Haemoglobin [From study start to end, up to 3.5 years]
Changes in haemoglobin from baseline to end of study
- Complete White Blood Cell Count [From study start to end, up to 3.5 years]
Changes in complete white blood cell count from baseline to end of study
Secondary Outcome Measures
- Measurement of Trough Total IgG Levels [From study start to end, up to 3.5 years]
Measurement of trough total IgG levels from baseline to end of study
- Number of Participants With Serious Bacterial Infections (SBIs). [From study start to end, up to 3.5 years]
Number of participants with serious bacterial infections
- SF-36 Health Survey. [From study start to end, up to 3.5 years]
Quality of Life for patients >= age 14 assessed using the Short Form 36 Health survey. Likert like scale. The responses given by patients were combined to create 8 SF-36 scores: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health 36 questions that fall into 4 Sub scale scoring ranges: Score 1-5: Where 1 is more favorable than 5 Score 1-3: Where 3 is more favorable than 1 Score 1-5: Where 5 is more favorable than 1 Score 1-6: Where 1 is more favorable than 6 The raw subscale scores are converted into a scale score between 0 to 100 using the Quality Metric Health Outcomes™ Scoring Software 2.0 Scale Title of final scales is: Physical and Mental Health Component Summary Scores Range: Lowest = 0 and highest = 100 where a high score equates to a more favorable health state
- CHQ-PF50 (Child Health Questionnaire-Parent Form) [From study start to end, up to 3.5 years]
Quality of Life for patients ages <14 years assessed using the CHQ-PF50. Measured values represent change in score from baseline to end of study. Two summary scores were derived: physical and psychosocial. In accord with the scoring manual, computed scores were transformed giving each scale a possible range from 0 to 100, with the exception of change in health, with a possible range from 1 to 5. For all CHQ-PF50 scales, higher scores indicated more positive functioning or better health status.
Eligibility Criteria
Criteria
Ages Eligible for Study:
2 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria for SCGAM-03:
-
Completion of the main study SCGAM-01, with good tolerance of Octanorm (as determined by the investigator).
-
For adult patients: freely given written informed consent. For patients below the legal age of majority: freely given written informed consent from parents/legal guardians and written informed assent from the child/adolescent in accordance with local requirements.
-
For female patients of child-bearing potential, a negative result in a urine pregnancy test conducted at the Screening visit.
-
Willingness to comply with all aspects of the protocol, including blood sampling, for the duration of the study.
Inclusion Criteria for SCGAM-03 in Canada:
Either:
SCGAM-01 patients (United States, Canada):
- Completion of the main study SCGAM-01, with good tolerance of octanorm (as determined by the investigator).
Or:
De novo patients (Canada only):
- C-a Age of ≥18 years and ≤75 years.
1C-b Confirmed diagnosis of PI as defined by ESID and PAGID and requiring immunoglobulin replacement therapy due to hypogammaglobulinaemia or agammaglobulinaemia. The exact type of PI should be recorded.
- C-c Availability of the IgG trough levels of 2 previous SCIG infusions before enrolment, and maintenance of ≥5.0 g/L in the trough levels of these 2 previous infusions.
And:
-
For adult patients: freely given written informed consent. For patients below the legal age of majority: freely given written informed consent from parents/legal guardians and written informed assent from the child/adolescent in accordance with local requirements.
-
For female patients of child-bearing potential, a negative result in a urine pregnancy test conducted at the Screening Visit.
-
Willingness to comply with all aspects of the protocol, including blood sampling, for the duration of the study.
Exclusion Criteria for SCGAM-03:
-
Subject being without any IgG treatment for period greater than approximately 5 weeks between the last infusion of Octanorm in the SCGAM-01 study and the first infusion of Octanorm in the SCGAM-03 study.
-
Exposure to blood or any blood product or derivative, other than IgG used for regular PID treatment, within the 3 months before the first infusion in this study.
-
Planned pregnancy during the course of the study.
Exclusion Criteria for SCGAM-03 in Canada:
- Either:
SCGAM-01 patients (United States, Canada):
1 Subject being without any IgG treatment for period greater than 5 weeks between the last infusion of octanorm in the SCGAM-01 study and the first infusion of octanorm in the SCGAM-03 study.
Or:
De novo patients (Canada only):
1C-a Acute infection requiring intravenous antibiotic treatment within 2 weeks prior to and during the screening period.
1C-b Known history of adverse reactions to IgA in other products.
1C-c Patients with body mass index >40 kg/m2.
1C-d Ongoing history of hypersensitivity or persistent reactions to blood or plasma derived products, or any component of the investigational product (such as Polysorbate 80).
1C-e Requirement of any routine premedication for IgG administration.
1C-f History of malignancies of lymphoid cells and immunodeficiency with lymphoma.
1C-g Severe liver function impairment (ALAT 3 times above upper limit of normal).
1C-h Known protein-losing enteropathies or proteinuria.
1C-i Presence of renal function impairment (creatinine >120 μM/L or creatinine >1.35 mg/dL), or predisposition for acute renal failure (e.g., any degree of pre-existing renal insufficiency or routine treatment with known nephritic drugs).
1C-j Treatment with oral or parenteral steroids for ≥30 days or when given intermittently or as bolus at daily doses ≥0.15 mg/kg.
1C-k Treatment with immunosuppressive or immunomodulatory drugs.
1C-l Live viral vaccination (such as measles, rubella, mumps and varicella) within the last 2 months prior to first infusion of octanorm.
And:
-
Exposure to blood or any blood product or plasma derivatives, other than SCIG used for regular PID treatment, within the 3 months before the first infusion of octanorm in this study.
-
Pregnant or nursing women or planned pregnancy during the course of the study.
-
Treatment with any investigational medicinal product (other than that of SCGAM-01) within 3 months prior to first infusion of octanorm.
-
Presence of any condition, that is likely to interfere with the evaluation of study medication or satisfactory conduct of the trial.
-
Known or suspected to abuse alcohol, drugs, psychotropic agents or other chemicals within the past 12 months prior to first infusion of octanorm.
-
Known or suspected HIV, HCV, or HBV infection.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Octapharma Research Site | Irvine | California | United States | 92697 |
| 2 | Octapharma Research Site | San Diego | California | United States | 92123 |
| 3 | Octapharma Research Site | Centennial | Colorado | United States | 80112 |
| 4 | Octapharma Research Site | Papillion | Nebraska | United States | 68046 |
| 5 | Octapharma Research Site | Toledo | Ohio | United States | 43617 |
| 6 | Octapharma Research Site | Frisco | Texas | United States | 75034 |
| 7 | Octapharma Research Site | Edmonton | Alberta | Canada | T6G2V2 |
Sponsors and Collaborators
- Octapharma
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Octapharma
ClinicalTrials.gov Identifier:
NCT03907241
Other Study ID Numbers:
- SCGAM-03 -
- NCT02627300
First Posted:
Apr 8, 2019
Last Update Posted:
Oct 27, 2020
Last Verified:
Oct 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Octanorm 16.5% |
|---|---|
| Arm/Group Description | octanorm 16.5%, human normal immunoglobulin for subcutaneous (SC) administration. Octanorm 16.5%: Human normal immunoglobulin |
| Period Title: Overall Study | |
| STARTED | 27 |
| COMPLETED | 23 |
| NOT COMPLETED | 4 |
Baseline Characteristics
| Arm/Group Title | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | Total of all reporting groups |
| Overall Participants | 2 | 4 | 4 | 17 | 27 |
| Age (years) [Median (Full Range) ] | |||||
| Median (Full Range) [years] |
6.50
|
9.00
|
14.25
|
56.12
|
39.26
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
0
0%
|
2
50%
|
2
50%
|
13
76.5%
|
17
63%
|
| Male |
2
100%
|
2
50%
|
2
50%
|
4
23.5%
|
10
37%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
2
100%
|
4
100%
|
4
100%
|
17
100%
|
27
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| White |
2
100%
|
4
100%
|
4
100%
|
15
88.2%
|
25
92.6%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
1
5.9%
|
1
3.7%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
1
5.9%
|
1
3.7%
|
| ABO Rhesus Blood Type (Count of Participants) | |||||
| A Blood Type |
1
50%
|
2
50%
|
2
50%
|
8
47.1%
|
13
48.1%
|
| AB Blood Type |
0
0%
|
0
0%
|
1
25%
|
1
5.9%
|
2
7.4%
|
| O Blood Type |
1
50%
|
2
50%
|
1
25%
|
8
47.1%
|
12
44.4%
|
Outcome Measures
| Title | Occurrence of All Treatment-emergent Adverse Events (TEAEs) |
|---|---|
| Description | Number of TEAEs |
| Time Frame | From study start to end, up to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 |
|---|---|---|---|---|
| Arm/Group Description | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% |
| Measure Participants | 2 | 4 | 4 | 17 |
| TEAEs excluding infections |
8
|
19
|
22
|
155
|
| Infections |
8
|
12
|
22
|
77
|
| Title | Occurrence of Temporally Associated TEAEs |
|---|---|
| Description | |
| Time Frame | From study start to end, up to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 |
|---|---|---|---|---|
| Arm/Group Description | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% |
| Measure Participants | 2 | 4 | 4 | 17 |
| Temporally Associated TEAEs excluding infections |
2
|
7
|
13
|
72
|
| Temporally Associated Infections |
5
|
6
|
11
|
45
|
| Title | Number of Temporally Associated TEAEs by Infusion Rate |
|---|---|
| Description | Number of temporally associated TEAEs by infusion rate. Only includes systemic TEAEs without infections and without infusion site reactions |
| Time Frame | From study start to end, up to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 |
|---|---|---|---|---|
| Arm/Group Description | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% |
| Measure Participants | 2 | 4 | 4 | 17 |
| Measure infusions | 2 | 7 | 13 | 72 |
| missing |
0
|
0
|
0
|
1
|
| 10 to <20ml/h |
1
|
0
|
0
|
0
|
| 20 to <30ml/hr |
1
|
1
|
0
|
0
|
| 30 to <40ml/hr |
0
|
6
|
0
|
6
|
| 40 to <50ml/hr |
0
|
0
|
9
|
28
|
| 50 to <60ml/hr |
0
|
0
|
4
|
3
|
| 60 to <70ml/hr |
0
|
0
|
0
|
2
|
| 70 to <80ml/hr |
0
|
0
|
0
|
4
|
| 80 to <90ml/hr |
0
|
0
|
0
|
6
|
| 90 to <100ml/hr |
0
|
0
|
0
|
22
|
| Title | Local Injection-site Reactions |
|---|---|
| Description | |
| Time Frame | From study start to end, up to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 |
|---|---|---|---|---|
| Arm/Group Description | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% |
| Measure Participants | 2 | 4 | 4 | 17 |
| Number [infusion site reactions] |
0
|
4
|
3
|
5
|
| Title | Blood Pressure |
|---|---|
| Description | Systolic and diastolic. |
| Time Frame | From study start to end, up to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 |
|---|---|---|---|---|
| Arm/Group Description | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% |
| Measure Participants | 2 | 4 | 4 | 17 |
| Systolic Blood Pressure at Screening |
100.00
(2.828)
|
105.00
(7.789)
|
116.60
(6.758)
|
126.21
(15.817)
|
| Systolic Blood Pressure End of Study |
102.50
(0.707)
|
103.00
(12.302)
|
114.00
(16.104)
|
127.24
(12.553)
|
| Diastolic Blood Pressure at Screening |
63.00
(11.314)
|
62.25
(6.551)
|
68.50
(2.380)
|
78.79
(9.407)
|
| Diastolic Blood Pressure at End of Study |
58.50
(13.435)
|
63.75
(6.702)
|
70.25
(12.842)
|
73.71
(8.130)
|
| Title | Body Temperature |
|---|---|
| Description | |
| Time Frame | From study start to end, up to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 |
|---|---|---|---|---|
| Arm/Group Description | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% |
| Measure Participants | 2 | 4 | 4 | 14 |
| Temperature at Screening |
36.85
(0.071)
|
36.98
(0.287)
|
36.63
(0.359)
|
36.56
(0.298)
|
| Temperature at End of Study |
36.55
(0.354)
|
36.58
(0.377)
|
36.65
(0.129)
|
36.57
(0.355)
|
| Title | Respiratory Rate |
|---|---|
| Description | |
| Time Frame | From study start to end, up to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not all recorded |
| Arm/Group Title | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 |
|---|---|---|---|---|
| Arm/Group Description | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% |
| Measure Participants | 2 | 4 | 4 | 17 |
| Respiratory Rate at Screening |
23.50
(6.364)
|
19.00
(3.830)
|
16.00
(0.000)
|
16.07
(2.129)
|
| Respiratory Rate at End of Study |
17.50
(2.121)
|
15.50
(1.000)
|
17.75
(2.630)
|
16.47
(2.625)
|
| Title | Sodium |
|---|---|
| Description | Changes in sodium levels from baseline to end of study |
| Time Frame | From study start to end, up to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not all assessed during visits |
| Arm/Group Title | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 |
|---|---|---|---|---|
| Arm/Group Description | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% |
| Measure Participants | 2 | 4 | 4 | 17 |
| Mean (Standard Deviation) [mmol/L] |
0.50
(0.707)
|
0.25
(1.258)
|
1.75
(2.217)
|
0.41
(2.238)
|
| Title | Potassium |
|---|---|
| Description | Changes in potassium levels from baseline to end of study |
| Time Frame | From study start to end, up to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 |
|---|---|---|---|---|
| Arm/Group Description | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% |
| Measure Participants | 2 | 4 | 4 | 17 |
| Mean (Standard Deviation) [mmol/L] |
0.35
(0.354)
|
0.25
(0.300)
|
0.18
(0.340)
|
-0.05
(0.726)
|
| Title | Blood Glucose |
|---|---|
| Description | Changes in blood glucose from baseline to end of study |
| Time Frame | From study start to end, up to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 |
|---|---|---|---|---|
| Arm/Group Description | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% |
| Measure Participants | 2 | 4 | 4 | 17 |
| Mean (Standard Deviation) [mmol/L] |
-1.03
(1.766)
|
3.49
(9.017)
|
0.22
(0.371)
|
-0.69
(1.672)
|
| Title | ALAT |
|---|---|
| Description | Changes in ALAT (alanine transaminase) from baseline to end of study |
| Time Frame | From study start to end, up to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 |
|---|---|---|---|---|
| Arm/Group Description | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% |
| Measure Participants | 2 | 4 | 4 | 17 |
| Mean (Standard Deviation) [U/L] |
-2.50
(2.121)
|
-5.75
(8.016)
|
-1.50
(16.135)
|
0.71
(4.074)
|
| Title | ASAT |
|---|---|
| Description | Changes in ASAT (aspartate aminotransferase) from baseline to end of study |
| Time Frame | From study start to end, up to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 |
|---|---|---|---|---|
| Arm/Group Description | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% |
| Measure Participants | 2 | 4 | 4 | 17 |
| Mean (Standard Deviation) [U/L] |
-3.00
(7.071)
|
-4.00
(5.354)
|
-3.00
(11.633)
|
0.59
(5.885)
|
| Title | LDH |
|---|---|
| Description | Changes in LDH (lactate dehydrogenase) from baseline to end of study |
| Time Frame | From study start to end, up to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 |
|---|---|---|---|---|
| Arm/Group Description | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% |
| Measure Participants | 2 | 4 | 4 | 17 |
| Mean (Standard Deviation) [U/L] |
23.50
(60.104)
|
-110.50
(131.751)
|
-52.50
(41.348)
|
-8.47
(26.779)
|
| Title | Total Bilirubin |
|---|---|
| Description | Changes in total bilirubin from baseline to end of study |
| Time Frame | From study start to end, up to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 |
|---|---|---|---|---|
| Arm/Group Description | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% |
| Measure Participants | 2 | 4 | 4 | 17 |
| Mean (Standard Deviation) [umol/L] |
0.86
(1.209)
|
0.94
(1.095)
|
1.58
(2.309)
|
0.52
(2.793)
|
| Title | Blood Urea Nitrogen |
|---|---|
| Description | Changes in blood urea nitrogen from baseline to end of study |
| Time Frame | From study start to end, up to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 |
|---|---|---|---|---|
| Arm/Group Description | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% |
| Measure Participants | 2 | 4 | 4 | 11 |
| Mean (Standard Deviation) [mmol/L] |
0.36
(1.010)
|
-2.12
(3.124)
|
0.09
(1.468)
|
-0.49
(1.154)
|
| Title | Creatinine |
|---|---|
| Description | Changes in creatinine from baseline to end of study |
| Time Frame | From study start to end, up to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 |
|---|---|---|---|---|
| Arm/Group Description | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% |
| Measure Participants | 2 | 4 | 4 | 17 |
| Mean (Standard Deviation) [umol/L] |
-4.86
(5.626)
|
-27.72
(54.837)
|
4.20
(6.431)
|
-0.62
(10.959)
|
| Title | Urine pH |
|---|---|
| Description | Changes in urine pH from baseline to end of study |
| Time Frame | From study start to end, up to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 |
|---|---|---|---|---|
| Arm/Group Description | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% |
| Measure Participants | 2 | 4 | 4 | 16 |
| Mean (Standard Deviation) [pH] |
0.00
(1.414)
|
0.13
(2.056)
|
-0.50
(0.913)
|
-0.34
(0.889)
|
| Title | Number of Participants With a Change in Urine Glucose |
|---|---|
| Description | Number of Participants with a Change in Urine Glucose |
| Time Frame | From study start to end, up to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 |
|---|---|---|---|---|
| Arm/Group Description | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% |
| Measure Participants | 2 | 4 | 4 | 17 |
| From Normal to Normal |
2
100%
|
4
100%
|
4
100%
|
15
88.2%
|
| From High Non-CS to Normal |
0
0%
|
0
0%
|
0
0%
|
1
5.9%
|
| Missing |
0
0%
|
0
0%
|
0
0%
|
1
5.9%
|
| Title | Number of Participants With a Change in Urine Ketones |
|---|---|
| Description | Number of Participants With a Change in Urine Ketones at baseline and end of study |
| Time Frame | From study start to end, up to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 |
|---|---|---|---|---|
| Arm/Group Description | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% |
| Measure Participants | 2 | 4 | 4 | 17 |
| From Normal to Normal |
2
100%
|
4
100%
|
4
100%
|
13
76.5%
|
| From Normal to High Non-CS |
0
0%
|
0
0%
|
0
0%
|
1
5.9%
|
| From High Non-CS to Normal |
0
0%
|
0
0%
|
0
0%
|
2
11.8%
|
| From High Non-CS to Missing |
0
0%
|
0
0%
|
0
0%
|
1
5.9%
|
| Title | Number of Participants With a Change in Urine Leukocytes |
|---|---|
| Description | Number of participants with a change in urine leukocytes at baseline and end of study |
| Time Frame | From study start to end, up to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 |
|---|---|---|---|---|
| Arm/Group Description | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% |
| Measure Participants | 2 | 4 | 4 | 17 |
| From Normal to Normal |
2
100%
|
3
75%
|
4
100%
|
14
82.4%
|
| From Normal to High Non-CS |
0
0%
|
0
0%
|
0
0%
|
1
5.9%
|
| From Normal to Missing |
0
0%
|
1
25%
|
0
0%
|
2
11.8%
|
| Title | Number of Participants With a Change in Urine Hemoglobin |
|---|---|
| Description | Number of participants with a change in urine hemoglobin at baseline and end of study |
| Time Frame | From study start to end, up to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 |
|---|---|---|---|---|
| Arm/Group Description | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% |
| Measure Participants | 2 | 4 | 4 | 17 |
| From Normal to Normal |
2
100%
|
4
100%
|
4
100%
|
14
82.4%
|
| From Normal to High Non-CS |
0
0%
|
0
0%
|
0
0%
|
1
5.9%
|
| From High Non-CS to Normal |
0
0%
|
0
0%
|
0
0%
|
1
5.9%
|
| From High Non-CS to Missing |
0
0%
|
0
0%
|
0
0%
|
1
5.9%
|
| Title | Complete Red Blood Cell Count |
|---|---|
| Description | Changes in complete red blood cell count from baseline to end of study |
| Time Frame | From study start to end, up to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 |
|---|---|---|---|---|
| Arm/Group Description | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% |
| Measure Participants | 2 | 4 | 4 | 17 |
| Mean (Standard Deviation) [10^12 cells/L] |
0.14
(0.311)
|
-0.06
(0.256)
|
0.17
(0.321)
|
0.01
(0.287)
|
| Title | Haematocrit |
|---|---|
| Description | Changes in haematocrit from baseline to end of study |
| Time Frame | From study start to end, up to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 |
|---|---|---|---|---|
| Arm/Group Description | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% |
| Measure Participants | 2 | 4 | 4 | 17 |
| Mean (Standard Deviation) [L/L] |
0.02
(0.034)
|
0.00
(0.013)
|
0.02
(0.032)
|
0.00
(0.030)
|
| Title | Haemoglobin |
|---|---|
| Description | Changes in haemoglobin from baseline to end of study |
| Time Frame | From study start to end, up to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 |
|---|---|---|---|---|
| Arm/Group Description | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% |
| Measure Participants | 2 | 4 | 4 | 17 |
| Mean (Standard Deviation) [g/L] |
8.00
(7.071)
|
-2.08
(4.198)
|
4.25
(11.673)
|
1.29
(8.513)
|
| Title | Complete White Blood Cell Count |
|---|---|
| Description | Changes in complete white blood cell count from baseline to end of study |
| Time Frame | From study start to end, up to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 |
|---|---|---|---|---|
| Arm/Group Description | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% |
| Measure Participants | 2 | 4 | 4 | 17 |
| Mean (Standard Deviation) [10^9 cells/L] |
1.45
(1.626)
|
-0.05
(1.034)
|
0.40
(1.655)
|
-0.24
(1.722)
|
| Title | Measurement of Trough Total IgG Levels |
|---|---|
| Description | Measurement of trough total IgG levels from baseline to end of study |
| Time Frame | From study start to end, up to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not all collected |
| Arm/Group Title | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 |
|---|---|---|---|---|
| Arm/Group Description | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% |
| Measure Participants | 2 | 4 | 4 | 17 |
| IgG at Screening |
10.99
(2.143)
|
11.92
(3.352)
|
12.17
(2.731)
|
13.17
(3.236)
|
| IgG at End of Study |
12.50
(3.048)
|
15.45
(7.359)
|
9.38
(1.842)
|
13.28
(3.336)
|
| Title | Number of Participants With Serious Bacterial Infections (SBIs). |
|---|---|
| Description | Number of participants with serious bacterial infections |
| Time Frame | From study start to end, up to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 |
|---|---|---|---|---|
| Arm/Group Description | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% |
| Measure Participants | 2 | 4 | 4 | 17 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
1
5.9%
|
| Title | SF-36 Health Survey. |
|---|---|
| Description | Quality of Life for patients >= age 14 assessed using the Short Form 36 Health survey. Likert like scale. The responses given by patients were combined to create 8 SF-36 scores: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health 36 questions that fall into 4 Sub scale scoring ranges: Score 1-5: Where 1 is more favorable than 5 Score 1-3: Where 3 is more favorable than 1 Score 1-5: Where 5 is more favorable than 1 Score 1-6: Where 1 is more favorable than 6 The raw subscale scores are converted into a scale score between 0 to 100 using the Quality Metric Health Outcomes™ Scoring Software 2.0 Scale Title of final scales is: Physical and Mental Health Component Summary Scores Range: Lowest = 0 and highest = 100 where a high score equates to a more favorable health state |
| Time Frame | From study start to end, up to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Age >=12 to <17 | Age >=17 to <=75 |
|---|---|---|
| Arm/Group Description | Octanorm 16.5% | Octanorm 16.5% |
| Measure Participants | 1 | 17 |
| Physical Health Score |
12.39
|
0.42
(6.922)
|
| Mental Health Score |
-1.12
|
0.38
(10.877)
|
| Title | CHQ-PF50 (Child Health Questionnaire-Parent Form) |
|---|---|
| Description | Quality of Life for patients ages <14 years assessed using the CHQ-PF50. Measured values represent change in score from baseline to end of study. Two summary scores were derived: physical and psychosocial. In accord with the scoring manual, computed scores were transformed giving each scale a possible range from 0 to 100, with the exception of change in health, with a possible range from 1 to 5. For all CHQ-PF50 scales, higher scores indicated more positive functioning or better health status. |
| Time Frame | From study start to end, up to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 |
|---|---|---|---|
| Arm/Group Description | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 |
| Measure Participants | 2 | 3 | 2 |
| Physical Summary Score |
-0.79
(5.032)
|
0.94
(6.800)
|
2.76
(2.683)
|
| Psychosocial Summary |
-9.07
(12.361)
|
0.50
(2.679)
|
9.92
(20.860)
|
Adverse Events
| Time Frame | From study start to end, up to 3.5 years | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 | ||||
| Arm/Group Description | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | Octanorm 16.5% | ||||
All Cause Mortality |
||||||||
| Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/17 (0%) | ||||
Serious Adverse Events |
||||||||
| Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/2 (0%) | 1/4 (25%) | 2/4 (50%) | 4/17 (23.5%) | ||||
| Gastrointestinal disorders | ||||||||
| Irritable bowel syndrome | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| General disorders | ||||||||
| Pyrexia | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Infections and infestations | ||||||||
| Diverticulitis | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Escherichia bacteraemia | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Infected bite | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Injury, poisoning and procedural complications | ||||||||
| Subdural haematoma | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Metabolism and nutrition disorders | ||||||||
| Hyponatraemia | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Osteoarthritis | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 2 |
| Spinal column stenosis | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Spinal osteoarthritis | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Nervous system disorders | ||||||||
| Seizure | 0/2 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/17 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Pleural effusion | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Pulmonary embolism | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/17 (0%) | 0 |
| Status asthmaticus | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 2 | 0/17 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
| Age >=2 to <6 | Age >=6 to <12 | Age >=12 to <17 | Age >=17 to <=75 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/2 (100%) | 4/4 (100%) | 4/4 (100%) | 14/17 (82.4%) | ||||
| Cardiac disorders | ||||||||
| Arteriosclerosis coronary artery | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Pericardial effusion | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Tachycardia | 0/2 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/17 (0%) | 0 |
| Ear and labyrinth disorders | ||||||||
| Eustachian tube dysfunction | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Endocrine disorders | ||||||||
| Autoimmune thyroiditis | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/17 (0%) | 0 |
| Hypothyroidism | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Eye disorders | ||||||||
| Cataract | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Conjunctivitis allergic | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Corneal infiltrates | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Eye pruritus | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Gastrointestinal disorders | ||||||||
| Abdominal pain | 0/2 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/17 (0%) | 0 |
| Abdominal pain upper | 0/2 (0%) | 0 | 1/4 (25%) | 2 | 0/4 (0%) | 0 | 0/17 (0%) | 0 |
| Aphthous ulcer | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Diarrhoea | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Gastritis | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Gastroesophageal reflux disease | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Gingival disorder | 0/2 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/17 (0%) | 0 |
| Irritable bowel syndrome | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Nausea | 1/2 (50%) | 3 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 1/17 (5.9%) | 1 |
| Vomiting | 1/2 (50%) | 1 | 1/4 (25%) | 1 | 1/4 (25%) | 1 | 0/17 (0%) | 0 |
| Dyspepsia | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| General disorders | ||||||||
| Chills | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 2 |
| Device dislocation | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Influenza like illness | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/17 (0%) | 0 |
| Oedema | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Pain | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 1/17 (5.9%) | 1 |
| Pyrexia | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Hepatobiliary disorders | ||||||||
| Cholelithiasis | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Immune system disorders | ||||||||
| Allergic Oedema | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Allergy to animal | 0/2 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/17 (0%) | 0 |
| Drug hypersensitivity | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 2 |
| Infections and infestations | ||||||||
| Diverticulitis | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 2 |
| Gastroenteritis viral | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Abscess | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Acute sinusitis | 1/2 (50%) | 1 | 1/4 (25%) | 1 | 1/4 (25%) | 1 | 1/17 (5.9%) | 1 |
| Bronchitis | 1/2 (50%) | 1 | 0/4 (0%) | 0 | 3/4 (75%) | 3 | 3/17 (17.6%) | 4 |
| Bronchitis viral | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/17 (0%) | 0 |
| Bronchopulmonary aspergillosis allergic | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Cellulitis | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 2/17 (11.8%) | 2 |
| Gastritis viral | 0/2 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/17 (0%) | 0 |
| Gastroenteritis | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Gastroenteritis viral | 1/2 (50%) | 2 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/17 (0%) | 0 |
| Gastrointestinal viral infection | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Gingivitis | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Helicobacter infection | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Infected bite | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 2 |
| Influenza | 1/2 (50%) | 1 | 1/4 (25%) | 2 | 2/4 (50%) | 3 | 3/17 (17.6%) | 3 |
| Infusion site infection | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Laryngitis | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Nasopharyngitis | 1/2 (50%) | 1 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 4/17 (23.5%) | 8 |
| Onychomycosis | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Otitis media | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/17 (0%) | 0 |
| Pharyngitis | 0/2 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/17 (0%) | 0 |
| Pharyngitis streptococcal | 0/2 (0%) | 0 | 1/4 (25%) | 2 | 1/4 (25%) | 1 | 0/17 (0%) | 0 |
| Pneumonia | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/17 (0%) | 0 |
| Respiratory tract infection viral | 1/2 (50%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/17 (0%) | 0 |
| Sinusitis | 1/2 (50%) | 1 | 1/4 (25%) | 1 | 2/4 (50%) | 6 | 8/17 (47.1%) | 29 |
| Sinusitis bacterial | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Sinusitis fungal | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Skin infection | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 1/17 (5.9%) | 1 |
| Staphylococcal skin infection | 0/2 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/17 (0%) | 0 |
| Subcutaneous abscess | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Tooth abscess | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Tooth infection | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 2/17 (11.8%) | 2 |
| Tracheobronchitis | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 2 | 0/17 (0%) | 0 |
| Upper respiratory tract infection | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 2 | 0/17 (0%) | 0 |
| Urinary tract infection | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 5/17 (29.4%) | 7 |
| Viral upper respiratory tract infection | 0/2 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Vulvovaginal mycotic infection | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Wound infection | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Injury, poisoning and procedural complications | ||||||||
| Animal bite | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 2/17 (11.8%) | 2 |
| Animal scratch | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Ankle fracture | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Burns second degree | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Clavicle fracture | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/17 (0%) | 0 |
| Exposure to communicable disease | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Fall | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 2 |
| Hand fracture | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Laceration | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Muscle contusion | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Muscle rupture | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Muscle strain | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Procedural pain | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Pulmonary contusion | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Rib fracture | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Road traffic accident | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/17 (0%) | 0 |
| Contusion | 0/2 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/17 (0%) | 0 |
| Spinal compression fracture | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Tooth fracture | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Investigations | ||||||||
| Alanine aminotransferase increased | 0/2 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 2/17 (11.8%) | 2 |
| Aspartate aminotransferase increased | 0/2 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 2/17 (11.8%) | 2 |
| Blood alcohol increased | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 2 |
| Blood bilirubin increased | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Blood lactate dehydrogenase | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Blood lactic acid increased | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Blood magnesium decreased | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Electrocardiogram abnormal | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Haematocrit decreased | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Haemoglobin decreased | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| International normalised ratio increased | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Neutrophil count decreased | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Platelet count decreased | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Red blood cell sedimentation rate increased | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| White blood cell count decreased | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Metabolism and nutrition disorders | ||||||||
| Hypercholesterolaemia | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 2/17 (11.8%) | 5 |
| Back pain | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 4/17 (23.5%) | 5 |
| Bursitis | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 2/17 (11.8%) | 3 |
| Exostosis | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Interverterbral disc degeneration | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Intervertebral disc protrusion | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 3 |
| Joint effusion | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Muscle spasms | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 2 |
| Musculoskeletal pain | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Neck pain | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Osteoarthritis | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 2/17 (11.8%) | 4 |
| Pain in extremity | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Scoliosis | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Spinal column stenosis | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 2 |
| Spinal osteoarthritis | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 2 |
| Spondylolisthesis | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 3 |
| Vertebral osteophyte | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Nervous system disorders | ||||||||
| Cervical radiculopathy | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Complex regional pain syndrome | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/17 (0%) | 0 |
| Headache | 0/2 (0%) | 0 | 2/4 (50%) | 2 | 1/4 (25%) | 1 | 2/17 (11.8%) | 3 |
| Hypoaesthesia | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Nerve compression | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 2/17 (11.8%) | 4 |
| Neuralgia | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Paraesthesia | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 2/17 (11.8%) | 2 |
| Presyncope | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Seizure | 0/2 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/17 (0%) | 0 |
| Tremor | 0/2 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Psychiatric disorders | ||||||||
| Tic | 1/2 (50%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/17 (0%) | 0 |
| Renal and urinary disorders | ||||||||
| Calculus ureteric | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Nephropathy | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Renal cyst | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Asthma | 0/2 (0%) | 0 | 2/4 (50%) | 2 | 1/4 (25%) | 2 | 1/17 (5.9%) | 3 |
| Cough | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 2/17 (11.8%) | 3 |
| Dypsnoea | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 2 |
| Hypopnoea | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Hypoxia | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Nasal congestion | 1/2 (50%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/17 (0%) | 0 |
| Oropharyngeal pain | 0/2 (0%) | 0 | 1/4 (25%) | 1 | 1/4 (25%) | 3 | 1/17 (5.9%) | 1 |
| Paranasal cyst | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Pleural effusion | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Sinus disorder | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Sleep apnoea syndrome | 1/2 (50%) | 1 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/17 (0%) | 0 |
| Upper-airway cough syndrome | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Vocal cord disorder | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/17 (0%) | 0 |
| Wheezing | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||||
| Acne | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 3 | 0/17 (0%) | 0 |
| Dermatitis contact | 1/2 (50%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 2/17 (11.8%) | 2 |
| Pruritus allergic | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 2 |
| Skin irritation | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 3 |
| Social circumstances | ||||||||
| Postmenopause | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Vascular disorders | ||||||||
| Hypertension | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/17 (5.9%) | 1 |
| Venous thrombosis limb | 0/2 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/17 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Mikaela Raymond |
|---|---|
| Organization | CRMG |
| Phone | 866-337-1868 |
| ctgov@clinicalresearchmgt.com |
Responsible Party:
Octapharma
ClinicalTrials.gov Identifier:
NCT03907241
Other Study ID Numbers:
- SCGAM-03 -
- NCT02627300
First Posted:
Apr 8, 2019
Last Update Posted:
Oct 27, 2020
Last Verified:
Oct 1, 2020