Brief Title
Study to Gain More Information on How Safe and Effective Jivi Works in Patients With Severe Hemophila A (Post-marketing Investigation)
Official Title
Post-marketing Investigation (PMI) to Assess Safety and Efficacy of Jivi (BAY 94-9027) Treatment in Participants With Hemophilia A
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, 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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
FVIII inhibitor development by the Nijmegen Bethesda assay
Secondary Outcome
Number of participants with treatment-emergent adverse events (TEAEs)
Condition
Hemophilia A
Intervention
Damoctocog alfa pegol (Jivi, BAY94-9027)
Study Arms / Comparison Groups
Severe hemophilia A patients
Description: Prophylactic treatment regimens should be guided by clinical judgement based on individual patient characteristics and treatment response.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
32
Start Date
September 23, 2019
Completion Date
July 5, 2022
Primary Completion Date
May 20, 2022
Eligibility 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.
Gender
Male
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
Bulgaria
Location Countries
Bulgaria
Administrative Informations
NCT ID
NCT04085458
Organization ID
19764
Secondary IDs
2018-003655-37
Responsible Party
Sponsor
Study Sponsor
Bayer
Study Sponsor
, ,
Verification Date
June 2022