Emicizumab in Patients With Acquired Hemophilia A: Multicenter, Single-arm, Open-label Clinical Trial

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a phase II multicenter open-label, single-arm prospective study to evaluate the efficacy of prophylactic emicizumab administered on a scheduled basis to prevent bleeds in patients with acquired hemophilia A (AHA).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Signed Informed Consent/Assent Form

• Age ≥18 years at time of signing Informed Consent Form

• Ability to comply with the study protocol, in the investigator's judgment

• Diagnosis of AHA based on a reduced FVIII activity (\<50 %) and positive FVIII inhibitor (\>0.6 BU/ml) at screening (local laboratory)

• Current bleeding due to AHA at the time of screening

• Plan to be adherent to emicizumab prophylaxis during the study

• For women of childbearing potential who meet the following criteria:

• Refrain from heterosexual intercourse or use contraceptive methods that result in a failure rate of \<1% per year during the study period A woman with ≥ 12 continuous months of amenorrhea with no identified cause other than menopause and has not undergone surgical sterilization (removal of ovaries and/or uterus). use of combined oral or injected hormonal contraceptive, bilateral tubal ligation, male sterilization, hormone- releasing intrauterine devices, and copper intrauterine devices.

Locations
United States
California
UCSD Hemophilia and Thrombosis Treatment Center
RECRUITING
San Diego
Washington, D.c.
Georgetown University
RECRUITING
Washington D.c.
Georgia
Emory University
RECRUITING
Atlanta
Illinois
Bleeding and Clotting Disorders Institute
RECRUITING
Peoria
Indiana
Indiana Hemophilia and Thrombosis Center, Inc.
RECRUITING
Indianapolis
Louisiana
Tulane University
RECRUITING
New Orleans
Minnesota
Mayo Clinic
RECRUITING
Rochester
Missouri
Washington University
RECRUITING
St Louis
North Carolina
University of North Carolina
RECRUITING
Chapel Hill
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Pennsylvania
Penn Blood Disorders Program, Hospital of the University of Pennsylvania
RECRUITING
Philadelphia
Hemophilia Center of Western Pennsylvania
RECRUITING
Pittsburgh
Virginia
UVA Comprehensive Cancer Center
RECRUITING
Charlottesville
Vermont
University of Vermont Medical Center
RECRUITING
Burlington
Washington
Washington Center for Bleeding Disorders
RECRUITING
Seattle
Wisconsin
Versiti Inc.
RECRUITING
Milwaukee
Contact Information
Primary
Danielle Matia, MPH
danielle.matia@wacbd.org
206-614-1157
Backup
Sarah Ruuska, MPH
sarah.ruuska@wacbd.org
2066497415
Time Frame
Start Date: 2022-08-31
Estimated Completion Date: 2025-12
Participants
Target number of participants: 51
Treatments
Experimental: Experimental-treatment
Treatment with emicizumab
Sponsors
Collaborators: Genentech, Inc.
Leads: University of Washington

This content was sourced from clinicaltrials.gov