Status:
COMPLETED
Study to Gain More Information on How Safe and Effective Jivi Works in Patients With Severe Hemophilia A (Post-marketing Investigation)
Lead Sponsor:
Bayer
Conditions:
Hemophilia A
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief Summary
The goal of this study is to give gather more information on how safe and well Jivi works in patients with severe hemophilia A. Jivi has been approved by various regulatory agencies, including the FDA...
Eligibility Criteria
Inclusion
- Participants must ≥ 18 years of age inclusive, at the time of signing the informed consent.
- Participants with severe hemophilia A (FVIII: C\<1%)
- PTPs (Previously treated patients) (≥150 ED (Exposure day)) on prophylaxis treatment before enrollment
- Participants who are immunocompetent. If human immunodeficiency virus (HIV) positive, cluster of differentiation 4 (CD4)+ lymphocyte count \>200/mm\*3
- Participants who are willing to complete an eDiary
- Male participants
- Capable of giving signed informed consent
Exclusion
- Any other inherited or acquired bleeding disorder in addition to Hemophilia A.
- Platelet count \< 100,000/mm\*3
- Creatinine \> 2x upper limit of normal
- AST or ALT \> 5x upper limit of normal (AST: aspartate aminotransferase; ALT: alanine aminotransferase)
- The participant has a planned major surgery.
- The participant is currently participating in another investigational drug study, or has participated in a clinical study involving an investigational drug within 30 days of signing informed consent or previous treatment in a clinical phase III study with BAY 94-9027 (now marketed as Jivi).
- Current evidence (by central laboratory) or history of inhibitor to FVIII with a titer ≥ 0.6 Bethesda unit (BU).
- Known hypersensitivity to the drug substance, excipients, or mouse or hamster protein.
Key Trial Info
Start Date :
September 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2022
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04085458
Start Date
September 23 2019
End Date
August 26 2022
Last Update
July 27 2023
Active Locations (13)
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1
UMHAT Tsaritsa Joanna-ISUL EAD Sofia
Sofia, Bulgaria, 1527
2
MHAT Sveta Marina EAD
Varna, Bulgaria, 9010
3
Aarhus Universitetshospital, Skejby
Arhus N, Denmark, 8200
4
LAIKO General Hospital of Athens
Athens, Greece, 115 27