CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 29 enrolled
Drug / intervention
OBI-1biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01178294
NCT01178294Phase 3Completed

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

Baxalta now part of Shire·interventional·Posted Aug 10, 2010·Updated May 13, 2021

In Brief

A Phase 3 clinical trial evaluating OBI-1 for Acquired Hemophilia A. Completed, enrolled 29 participants across 12 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, India, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 10, 2010
Enrollment StartNov 10, 2010
Primary CompletionJul 1, 2013
Study CompletionOct 9, 2013
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 15.9 years ago

Interventions

OBI-1biological

Intravenous infusion