NCT01178294

Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Acquired Hemophilia A

Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to test whether the study drug (OBI-1) is safe and effective for the treatment of serious bleeding episodes in people with acquired hemophilia A.

Conditions

• Acquired Hemophilia A

Interventions

Type	Name	Description
BIOLOGICAL	OBI-1	Intravenous infusion

Timeline

• Start date: 2010-11-10
• Primary completion: 2013-07-01
• Completion: 2013-10-09
• First posted: 2010-08-10
• Last updated: 2021-05-13
• Results posted: 2015-12-21

Locations

12 sites across 4 countries: United States, Canada, India, United Kingdom