Study to Gain More Information on How Safe and Effective Jivi Works in Patients With Severe Hemophila A (Post-marketing Investigation)

• Status: Active, not recruiting
• Trial end date: 2022-07-27
• Target enrollment: 0
• Participant gender: Male

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, Health Canada, Japanese Health Authority and the European Medicinal Agency. 25 patients will be enrolled and will stay for 1 to 2 years in this study depending on their treatment frequency. Researcher will monitor during the course of the study whether patients are developing antibodies (a protein made by the body in response to the drug) affecting the effectiveness of Jivi. In addition information on bleedings and patient's wellbeing will be collected.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Factor VIII

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.