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

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.

Timeline

Start

2010-11-10

Primary completion

2013-07-01

Completion

2013-10-09

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

registry NUMBER OBI-1: 100 (88.1 to 100) percentage of serious bleeding episodes NCT01178294 ↗

registry OBI-1; p <0.001; one-sided binomial exact test NCT01178294 ↗

Publications

• Results Kruse-Jarres R, St-Louis J, Greist A, Shapiro A, Smith H, Chowdary P, Drebes A, Gomperts E, Bourgeois C, Mo M, Novack A, Farin H, Ewenstein B. Efficacy and safety of OBI-1, an antihaemophilic factor VIII (recombinant), porcine sequence, in subjects with acquired haemophilia A. Haemophilia. 2015 Mar;21(2):162-170. doi: 10.1111/hae.12627. Epub 2015 Jan 27.
• Miesbach W, Curry N, Knobl P, Percy C, Santoro R, Schmaier AH, Trautmann-Grill K, Badejo K, Chen J, Nouri M, Oberai P, Klamroth R. Real-world use of recombinant porcine sequence factor VIII in the treatment of acquired hemophilia A: EU PASS. Ther Adv Hematol. 2024 Sep 2;15:20406207241260332. doi: 10.1177/20406207241260332. eCollection 2024.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	OBI-1	Protein / enzyme biologic	200 iu/kg	Intravenous

Indications