Minimize Menorrhagia in Women With Von Willebrand Disease

Stopped early · Phase 3

Conditions studied: Von Willebrand Diseases

In brief

This is an outpatient, 24-week Phase III prospective, randomized, crossover trial comparing recombinant von Willebrand factor (rVWF) and tranexamic acid (TA, Lysteda®) to minimize menorrhagia in women with von Willebrand disease (VWD). The purpose of this Phase III multicenter prospective, randomized, crossover arm trial is to compare recombinant von Willebrand factor (rVWF) to tranexamic acid (TA) in reducing the severity of menorrhagia in women with von Willebrand disease.

Key facts

Study ID

NCT02606045

Run by

Margaret Ragni

People needed

39

Starts

2019-02-07

Expected to finish

2022-08-30

Last updated by the study team

2024-07-01

Who can join

Age: 13 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Adult females 13-45 years of age.
• Mild or moderate von Willebrand disease (VWF:RCo <0.50 IU/ml, normal multimers, past bleeding)
• Menorrhagia defined as PBAC >100 in at least one of the last two menstrual cycles.
• Regular menses, at least every 21-35 days.
• Willingness to have blood drawn
• No prior history of an allergic reaction or anaphylaxis to rVWF or TA.
• Willingness to avoid aspirin (ASA) and nonsteroidal anti-inflammatory agents (NSAIDS) during the study.
• Willingness to comply with randomization to rVWF or TA study arms.
• Willingness to keep a personal diary of menorrhagia bleeding frequency duration and severity by pictorial blood assessment chart, and any drugs or hemostatic agents taken.
• Willingness to make 4 visits and undergo blood sampling for coagulation studies, and accept randomization of two therapies for each of four consecutive menstrual cycles, including an end-of-study visit.
• Willingness to use "double-barrier" method of contraception during the study.

You may not qualify if…

• Any bleeding disorder other than von Willebrand disease; or past thrombotic disease
• Pregnant or lactating, or use of hormones (other than progesterone-only), or combined oral contraceptives, and contraceptive implants in past 3 months.
• Platelet count < 100,000/ul.
• Use of immunomodulatory or experimental drugs.
• Surgery within the past 8 weeks.
• Concomitant use of antiplatelet drugs, anticoagulants, dextran, aspirin or NSAIDs.
• Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives containing VWF within 5 days of study.
• Inability to comply with study requirements.
• Hypothyroidism as defined by elevated TSH.
• Iron deficiency as defined by low serum ferritin, unless iron replacement has been initiated.
• History of renal disease

Where it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• Center for Inherited Blood Disorders (CIBD) — Orange, California, United States
• University of California San Francisco — San Francisco, California, United States
• Emory University Afflac Blood Disorders Center — Atlanta, Georgia, United States
• Henry Ford Hospital Medical Center — Detroit, Michigan, United States
• Michigan State University — East Lansing, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University St. Louis — St Louis, Missouri, United States
• Cure4thekids Foundation — Las Vegas, Nevada, United States
• Rutgers Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
• State University of New York Upstate Medical Center — Syracuse, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• University of Pittsburgh and Hemophilia Center Western PA — Pittsburgh, Pennsylvania, United States
• Vanderbilty University — Nashville, Tennessee, United States
• University of Utah — Salt Lake City, Utah, United States
• Bloodworks Northwest — Seattle, Washington, United States
• Versiti Blood Center of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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