Phase 4
N=32
Study to Gain More Information on How Safe and Effective Jivi Works in Patients With Severe Hemophilia A (Post-marketing Investigation)
Hemophilia A
Bottom Line
View on ClinicalTrials.gov: NCT04085458 ↗Enrolled (actual)
32
Serious AEs
6.3%
Results posted
Jun 2023
Primary outcome: Primary: FVIII Inhibitor Development by the Nijmegen Bethesda Assay — 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Damoctocog alfa pegol (Jivi, BAY94-9027) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Bayer
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY FVIII Inhibitor Development by the Nijmegen Bethesda Assay |
0; 0; 0 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
21; 3; 0; 2; 2; 0 | — |
| SECONDARY Development of Treatment-emergent Anti-PEG Antibodies |
3 | — |
| SECONDARY Annualized Bleeding Rate (ABR) |
1.8 | — |
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.
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 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 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.
Data sourced from ClinicalTrials.gov (NCT04085458). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.