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

Bayer

Status and phase

Completed

Phase 4

Conditions

Hemophilia A

Treatments

Drug: Damoctocog alfa pegol (Jivi, BAY94-9027)

Study type

Interventional

Funder types

Industry

Identifiers

NCT04085458

2018-003655-37 (EudraCT Number)

19764

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.