Minimize Menorrhagia in Women With Von Willebrand Disease

PHASE3TerminatedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

February 7, 2019

Primary Completion Date

April 30, 2022

Study Completion Date

August 30, 2022

Conditions
Von Willebrand Diseases
Interventions
DRUG

recombinant von Willebrand factor

"Group I will receive Arm A recombinant von Willebrand factor 40 IU/kg intravenously (IV) infusion on day 1 of each of two menstrual cycles, Cycles 1 and 2. They will then be crossed over to Arm B, TA 650 mg 2 tablets orally (po) three times daily on days 1-5 of each of two menstrual cycles, Cycles 3 and 4.~Group II will receive Arm B, TA 650 mg 2 tablets orally (po) three times daily on days 1-5, for each of two menstrual cycles, Cycles 1 and 2. They will then be crossed over to Arm A, rVWF 40 IU/kg intravenously (IV) infusion on day 1 on each of two menstrual cycles, Cycles 3 and 4."

DRUG

tranexamic acid

"Group I will receive Arm A recombinant von Willebrand factor 40 IU/kg intravenously (IV) infusion on day 1 of each of two menstrual cycles, Cycles 1 and 2. They will then be crossed over to Arm B, TA 650 mg 2 tablets orally (po) three times daily on days 1-5 of each of two menstrual cycles, Cycles 3 and 4.~Group II will receive Arm B, TA 650 mg 2 tablets orally (po) three times daily on days 1-5, for each of two menstrual cycles, Cycles 1 and 2. They will then be crossed over to Arm A, rVWF 40 IU/kg intravenously (IV) infusion on day 1 on each of two menstrual cycles, Cycles 3 and 4."

Trial Locations (19)

13210

State University of New York Upstate Medical Center, Syracuse

15213

University of Pittsburgh and Hemophilia Center Western PA, Pittsburgh

30322

Emory University Afflac Blood Disorders Center, Atlanta

37322

Vanderbilty University, Nashville

43210

Ohio State University Wexner Medical Center, Columbus

44195

Cleveland Clinic Foundation, Cleveland

48202

Henry Ford Hospital Medical Center, Detroit

48824

Michigan State University, East Lansing

53226

Versiti Blood Center of Wisconsin, Milwaukee

55902

Mayo Clinic, Rochester

63110

Washington University St. Louis, St Louis

84132

University of Utah, Salt Lake City

85234

Banner MD Anderson Cancer Center, Gilbert

89135

Cure4thekids Foundation, Las Vegas

92868

Center for Inherited Blood Disorders (CIBD), Orange

94117

University of California San Francisco, San Francisco

97239

Oregon Health and Science University, Portland

98104

Bloodworks Northwest, Seattle

08901

Rutgers Robert Wood Johnson Medical School, New Brunswick

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

University of North Carolina

OTHER

collaborator

Duke University

OTHER

collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Margaret Ragni

OTHER

NCT02606045 - Minimize Menorrhagia in Women With Von Willebrand Disease | Biotech Hunter | Biotech Hunter