FEIBA Reconstitution Volume Reduction and Faster Infusion Study (FEIBA STAR)
Study Details
Study Description
Brief Summary
The purpose of this study is to:
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- To evaluate the tolerability and safety of infusing reduced volume Factor Eight Inhibitor Bypassing Activity (FEIBA) at the standard infusion rate of 2 U/kg/min
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- To evaluate the tolerability and safety of infusing reduced volume FEIBA at increased rates of 4 and 10 U/kg/min, in comparison to the standard rate of 2 U/kg/min at the regular volume
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
15 JUN 2020: The temporary enrollment stop of new patients into this study due to the COVID-10 pandemic has been lifted in one or more countries/sites, and the study is now again enrolling new patients. However, some countries/sites may still have paused the enrollment of new patients due to the pandemic.
23 APRIL 2020: Enrollment of new patients into this study has been paused due to the COVID-19 situation. The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part 1 Regular then reduced volume Part 2 Faster infusion rate STUDY PART 1- FEIBA reconstituted in regular volume then FEIBA reconstituted in 50% reduced volume; STUDY PART 2- Infusion rate escalation to 4 U/min/kg and reconstituted in 50% reduced volume; Followed by FEIBA reconstituted in 50% reduced volume with infusion rate: 4 U/min/kg; Followed by FEIBA reconstituted in 50% reduced volume with infusion rate: 10 U/min/kg. |
Biological: FEIBA
Anti-inhibitor Coagulant Complex Nanofiltered (activated prothrombin complex concentrate [APCC]), FEIBA NF.
Other Names:
|
| Experimental: Part 1 Reduced then regular volume Part 2 Faster infusion rate STUDY PART 1- FEIBA Reconstituted in 50% Reduced Volume then FEIBA Reconstituted in Regular Volume; STUDY PART 2- Infusion rate escalation to 4 U/min/kg and reconstituted in 50% reduced volume; Followed by FEIBA reconstituted in 50% reduced volume with infusion rate: 4 U/min/kg; Followed by FEIBA reconstituted in 50% reduced volume with infusion rate: 10 U/min/kg. |
Biological: FEIBA
Anti-inhibitor Coagulant Complex Nanofiltered (activated prothrombin complex concentrate [APCC]), FEIBA NF.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events [Throughout the study period of approximately 13 months]
Number of participants with serious adverse events (SAEs) and non-SAEs will be assessed.
- Number of Participants With Adverse Events (AEs) Related to Hypersensitivity Reactions [Throughout the study period of approximately 13 months]
Number of participants with AEs particular to allergic-type hypersensitivity reactions will be assessed.
- Number of Participants With Adverse Events (AEs) Related to Thromboembolic Events [Throughout the study period of approximately 13 months]
Number of participants with AEs particular to thromboembolic events will be assessed.
- Number of Participants With Adverse Events (AEs) Related to Infusion Site Reactions [Throughout the study period of approximately 13 months]
Number of participants with AEs related to infusion site reactions will be assessed.
- Number of Participants With Adverse Events (AEs) Leading to Discontinuation [Throughout the study period of approximately 13 months]
Number of participants with adverse events (AEs) leading to discontinuation will be assessed.
- Number of Participants With Adverse Events (AEs) Related to Change in Vital Signs [Throughout the study period of approximately 13 months]
Number of participants with AEs related to change in vital signs will be assessed. Vital signs will include body temperature (degree Celsius or degrees Fahrenheit [°C or °F]), respiratory rate (breaths/min), pulse rate (beats/min), and systolic and diastolic blood pressure (millimeter of mercury [mmHg]).
- Number of Participants With Adverse Events (AEs) Related to Change in Laboratory Assessments [Throughout the study period of approximately 13 months]
Number of participants with AEs related to change in laboratory assessments will be assessed. Laboratory assessments include hematology, clinical chemistry, coagulation testing, serological testing, pregnancy testing, cluster differentiation 4 (CD4).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Greater than or equal to (> or =) 18 to less than or equal to (< or =) 65 years old at the time of screening.
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Hemophilia A or B of any severity, with a documented > or = 3 months history of inhibitors (> or = 0.6 Bethesda units [BU]) requiring the use of bypassing agents (FEIBA or rFVIIa) prior to screening. Inhibitor level will be tested at screening if no documented history is available.
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Hepatitis C virus (HCV) negative, either by antibody testing or polymerase chain reaction (PCR); or HCV positive with stable liver disease.
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Human immune deficiency virus (HIV) negative; or HIV positive with stable disease and CD4 count > or = 200 cells per cubic millimetre (cell/mm3) at screening.
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Adequate venous access.
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Willing and able to comply with the requirements of the protocol.
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If a female of childbearing potential, must have a negative blood pregnancy test and agrees to employ adequate birth control measures for the duration of the study, such as: a. Abstain from sexual intercourse, b. Use a reliable method of contraception (contraception such as an intrauterine device, barrier method [e.g., diaphragm or sponge; female condom not permitted] with spermicide, oral contraceptive, injectable progesterone, sub dermal implant), and have their male partner use a condom
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If female of non-childbearing potential, confirmed at screening by fulfilling 1 of the following criteria:
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Postmenopausal, defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and with follicle-stimulating hormone levels within the laboratory-defined postmenopausal range or postmenopausal with amenorrhea for at least 24 months and on hormonal replacement therapy.
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Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, bilateral tubal ligation (with no subsequent pregnancy at least 1 year from bilateral tubal ligation), or bilateral salpingectomy.
Exclusion criteria:
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Known hypersensitivity to FEIBA or any of its components.
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Advanced liver disease (e.g., liver biopsy confirmed diagnosis of cirrhosis, portal vein hypertension, ascites, prothrombin time [PT] 5 seconds above upper limit of normal).
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Planned elective surgery during participation in this study (excluding minor procedures that will not need preventative bleeding treatments, such as exchanges of peripherally inserted central catheters).
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Platelet count less than (<) 100,000/ microliter (μL).
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Taking Emicizumab (Hemlibra) for bleed prevention.
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Clinical or laboratory evidence of disseminated intravascular coagulation based on medical history.
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Prior history or evidence of thromboembolic event: acute myocardial infarction, deep vein thrombosis, pulmonary embolism, etc.
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Diagnosis of advanced atherosclerosis, malignancy, and/or other diseases that may increase the participant's risk of thromboembolic complications.
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Participant is taking any immunomodulating drug (e.g., corticosteroid agents at a dose equivalent to hydrocortisone greater than (>) 10 milligram per day (mg/day), or α-interferon) within 30 days prior to enrollment except anti-retroviral chemotherapy.
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Herbal supplements that contain anti-platelet activity.
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Participant has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study.
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Participant is a family member or employee of the investigator.
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Clinically significant medical, psychiatric or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect participant safety or compliance.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Center Zagreb | Zagreb | Croatia | 10 000 | |
| 2 | PHI Institute for Transfusion Medicine of Macedonia | Skopje | North Macedonia | 1000 | |
| 3 | MV Sklifosovskyi Poltava Hematology | Poltava | Ukraine | 36011 |
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)
None provided.More Information
Additional Information:
Publications
None provided.- 091501
- 2015-005781-39