NCT01708564

A Phase I Safety, Pharmacokinetics and Pharmacodynamics Study of Recombinant Factor VIIa in Adult Patients With Hemophilia A or B

A Phase 1b, Dose Escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: rEVO Biologics · Industry
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the pharmacokinetics and pharmacodynamics of rhFVIIa at three dose levels. The results will help identify the most optimal doses to take forward to the Phase 2/3 studies where bleedings in hemophilia patients with inhibitors will be treated with rhFVIIa.

Conditions

• Hemophilia

Interventions

Type	Name	Description
BIOLOGICAL	rhFVIIa	Patients will be administered low, intermediate and high doses of rhFVIIa

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2012-10-17
• Last updated: 2013-07-30

Locations

3 sites across 2 countries: United States, Netherlands