A Study Comparing Recombinant Von Willebrand Factor (rVWF) vs. Tranexamic Acid (TA) to Minimize Menorrhagia in Women with Type 1 Von Willebrand Disease

Overview

About this study

The purpose of this study is to compare recombinant Von Willebrand Factor (rVWF) vs. Tranexamic Acid (TA) to minimize menorrhagia in women with Type 1 Von Willebrand disease.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Adult females 16-45 years of age.
  • Mild or moderate von Willebrand disease (VWF:RCo <0.50 IU/ml, past bleeding.
  • Menorrhagia and a 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 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, 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.

Exclusion Criteria:

  • Any bleeding disorder other than von Willebrand disease; or past thrombotic disease
  • Pregnant or lactating, or use of hormones or oral contraceptives or contraceptive implant 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Rajiv Pruthi, M.B.B.S.

Contact us for the latest status

Contact information:

Sandra Heisler L.P.N.

(507) 284-5095

heisler.sandra@mayo.edu

More information

Publications

  • von Willebrand disease (VWD) is the most common congenital bleeding disorder. In women, menorrhagia is the most common bleeding symptom, and is disabling with iron deficiency anaemia, high health cost and poor quality of life. Current hormonal and non-hormonal therapies are limited by ineffectiveness and intolerance. Few data exist regarding von Willebrand factor (VWF), typically prescribed when other treatments fail. The lack of effective therapy for menorrhagia remains the greatest unmet healthcare need in women with VWD. Better therapies are needed to treat women with menorrhagia. Read More on PubMed

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20445686

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