NCT03361137

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

A Phase IV, Multicenter, Single-Arm, Open-Label Study of Emicizumab Prophylaxis in Patients With Hemophilia A With or Without Inhibitors Undergoing Minor Surgical Procedures

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Conditions

• Hemophilia A

Interventions

Type	Name	Description
DRUG	Emicizumab	Emicizumab via SC injection at a loading dose 3 mg/kg once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly, or by any other approved maintenance regimen, as long as the participant continues to derive sufficient benefit. Dosing was to be adjusted if the participant had a significant change in body weight.

Timeline

• Start date: 2018-06-28
• Primary completion: 2020-03-13
• Completion: 2020-03-13
• First posted: 2017-12-04
• Last updated: 2021-03-01
• Results posted: 2021-03-01

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study