NCT04548791

Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Inherited Bleeding Disorders

Phase 1/2 Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Marzeptacog Alfa (Activated) in Treatment of Episodic Bleeding in Subjects With Inherited Bleeding Disorders

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Catalyst Biosciences · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the trial is to evaluate the PK, bioavailability, PD, efficacy and safety of MarzAA for on demand treatment and control of bleeding episodes in adult subjects with inherited bleeding disorders.

Conditions

• Factor VII Deficiency
• Glanzmann Thrombasthenia
• Hemophilia A With Inhibitor

Interventions

Type	Name	Description
BIOLOGICAL	Coagulation Factor VIIa variant	Single intravenous dose and ascending doses of subcutaneous injection of MarzAA, followed by a fixed dose of MarzAA for the treatment of bleeding episodes

Timeline

• Start date: 2021-05-17
• Primary completion: 2021-11-15
• Completion: 2021-12-03
• First posted: 2020-09-16
• Last updated: 2021-12-21

Locations

20 sites across 5 countries: United States, India, Italy, Russia, Ukraine

Regulatory

• FDA-regulated drug study