Study of Emicizumab Prophylaxis in Participants With Hemophilia A With or Without Inhibitors Undergoing Minor Surgical Procedures

Phase 4 Terminated 14 enrolled Genentech, Inc.

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This Phase IV, multicenter study will evaluate whether participants with Hemophilia A (PwHA) with or without inhibitors receiving emicizumab prophylaxis can safely undergo minor surgical procedures without additional prophylactic bypassing agents (BPA; for participants with inhibitors) or factor VIII (FVIII; for participants without inhibitors).

Timeline

Start: 2018-06-28
Primary completion: 2020-03-13
Completion: 2020-03-13

Outcome

Outcome not reported

Stopped (Enrollment): “The Sponsor decided to terminate the study early for several reasons (low enrollment, limited variety of surgery types, and available scientific data).”

Publications

Background Blanchette VS, Key NS, Ljung LR, Manco-Johnson MJ, van den Berg HM, Srivastava A; Subcommittee on Factor VIII, Factor IX and Rare Coagulation Disorders of the Scientific and Standardization Committee of the International Society on Thrombosis and Hemostasis. Definitions in hemophilia: communication from the SSC of the ISTH. J Thromb Haemost. 2014 Nov;12(11):1935-9. doi: 10.1111/jth.12672. Epub 2014 Sep 3. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Emicizumab	Monoclonal antibody	1.5 mg/kg	Subcutaneous