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

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 18-005195
    Sponsor Protocol Number: PRO15070638

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. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria:

 

  • Adult females 18-45 years of age.
  • Mild or moderate type 1 von Willebrand disease (VWF:RCo <0.50 IU/ml, normal multimers, 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 us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Rajiv Pruthi, M.B.B.S.

Open for enrollment

Contact information:

Sandra Heisler L.P.N.

(507)284-5095

heisler.sandra@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

.
CLS-20445686

Mayo Clinic Footer