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