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Trial record 19 of 44 for:    "Hemophilia" | "Antibodies"

An Expanded Access Program of Emicizumab in Participants With Hemophilia A With Inhibitors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03154437
Expanded Access Status : Approved for marketing
First Posted : May 16, 2017
Last Update Posted : March 29, 2018
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date May 12, 2017
First Posted Date May 16, 2017
Last Update Posted Date March 29, 2018
Descriptive Information
Brief Title An Expanded Access Program of Emicizumab in Participants With Hemophilia A With Inhibitors
Brief Summary This open-label, multicenter expanded access program (EAP) is designed to provide emicizumab to eligible participants with hemophilia A with factor VIII (FVIII) inhibitors before it is commercially available in the United States for the indication of hemophilia A with FVIII inhibitors. Discontinuation may occur earlier if participant or physician decides to discontinue treatment or the sponsor discontinues emicizumab clinical development.
Detailed Description Not Provided
Study Type Expanded Access
Expanded Access Type Treatment IND/Protocol
Intervention Biological: Emicizumab
Participants will receive emicizumab at a loading dose of 3 milligrams per kilogram (mg/kg) per week subcutaneously (SC) for 4 weeks, followed by a maintenance dose of 1.5 mg/kg per week SC thereafter. Treatment with emicizumab will continue until unacceptable toxicity, withdrawal of consent, participant or physician decision to discontinue treatment, death, the participant is able to obtain commercial drug after emicizumab becomes commercially available, or the sponsor decides to discontinue emicizumab clinical development, whichever occurs first.
Other Names:
  • ACE910
  • CH5534262
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Expanded Access Status Approved for marketing
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT03154437
Responsible Party Genentech, Inc.
Study Sponsor Genentech, Inc.
Collaborators Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Genentech, Inc.
Verification Date March 2018