Trials / Terminated
TerminatedNCT03597022
Multiple Escalating Dose Study of BAY1093884 in Adults With Hemophilia A or B With or Without Inhibitors
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study was to assess the safety and tolerability of multiple doses of a human monoclonal antibody (BAY1093884) given under the skin in subjects with hemophilia A or B. This antibody was intended to protect from bleeds by inhibiting a substance (Tissue Factor Pathway Inhibitor, TFPI) that reduces the ability of the body to form blood clots.
Detailed description
The primary objective of the study was to assess the safety and tolerability of multiple subcutaneous injections of BAY1093884 (anti-TFPI monoclonal antibody, immunoglobulin G2, IgG2) in patients with hemophilia A or B with or without inhibitors.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Befovacimab (BAY1093884) | Once weekly doses until premature termination of the study, subcutaneous injection |
Timeline
- Start date
- 2018-07-24
- Primary completion
- 2019-10-15
- Completion
- 2019-10-15
- First posted
- 2018-07-24
- Last updated
- 2020-11-30
- Results posted
- 2020-11-30
Locations
17 sites across 11 countries: Australia, Austria, Bulgaria, France, Hungary, Italy, Japan, New Zealand, South Korea, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03597022. Inclusion in this directory is not an endorsement.