Trials / Terminated
TerminatedNCT04489537
Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Hemophilia A or B
Phase 3 Study to Evaluate the Efficacy and Safety of Subcutaneous Marzeptacog Alfa (Activated) For On Demand Treatment and Control of Bleeding Episodes in Subjects With Hemophilia A or Hemophilia B, With Inhibitors: The Crimson 1 Study
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Catalyst Biosciences · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the trial is to evaluate the safety and efficacy of MarzAA for on-demand treatment and control of bleeding episodes in hemophilia A or B patients with inhibitors compared with their standard of care (SOC).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MarzAA | A cross over design to assess the efficacy of a dosing regimen of 60 µg/kg of MarzAA compared with standard of care for the treatment of bleeding episodes. |
Timeline
- Start date
- 2021-05-04
- Primary completion
- 2021-11-15
- Completion
- 2021-12-01
- First posted
- 2020-07-28
- Last updated
- 2021-12-17
Locations
43 sites across 16 countries: United States, Armenia, Georgia, Hungary, India, Italy, Malaysia, Mexico, Poland, Russia, South Africa, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04489537. Inclusion in this directory is not an endorsement.