CTRI/2020/01/022716
Active, not recruiting
Phase 3
A Phase 3, Prospective, Multicenter, Open-label, Randomized, Crossover Study of Tolerability and Safety of FEIBA Reconstituted in Regular or 50% Reduced Volume and of Faster Infusion Rates in Patients with Hemophilia A or B with Inhibitors
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Baxalta Innovations GmbH
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.ââ?°Â¥ 18 to ââ?°Â¤ 65 years old at the time of screening
- •2\.Hemophilia A or B of any severity, with a documented ââ?°Â¥ 3 months history of inhibitors (ââ?°Â¥ 0\.6 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.
- •3\.Hepatitis C virus (HCV) negative, either by antibody testing or polymerase chain reaction (PCR); or HCV positive with stable liver disease
- •4\.Human immune deficiency virus (HIV) negative; or HIV positive with stable disease and CD4 count ââ?°Â¥ 200 cell/mm3 at screening
- •5\.Adequate venous access
- •6\.Willing and able to comply with the requirements of the protocol
- •7\.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
- •8\.If female of non\-childbearing potential, confirmed at screening by fulfilling 1 of the following criteria:
Exclusion Criteria
- •Inclusion criteria
- •Subject is/has:
- •1\.ââ?°Â¥ 18 to ââ?°Â¤ 65 years old at the time of screening
- •2\.Hemophilia A or B of any severity, with a documented ââ?°Â¥ 3 months history of inhibitors (ââ?°Â¥ 0\.6 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.
- •3\.Hepatitis C virus (HCV) negative, either by antibody testing or polymerase chain reaction (PCR); or HCV positive with stable liver disease
- •4\.Human immune deficiency virus (HIV) negative; or HIV positive with stable disease and CD4 count ââ?°Â¥ 200 cell/mm3 at screening
- •5\.Adequate venous access
- •6\.Willing and able to comply with the requirements of the protocol
- •7\.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
Outcomes
Primary Outcomes
Not specified
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