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Coagulation Factor Replacement Therapy

Recombinant von Willebrand Factor + Tranexamic Acid for Heavy Menstrual Bleeding (VWDMin Trial)

Phase 3
Waitlist Available
Led By Margaret V Ragni, MD, MPH
Research Sponsored by Margaret Ragni
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult females 13-45 years of age
Mild or moderate von Willebrand disease (VWF:RCo <0.50 IU/ml, normal multimers, past bleeding)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

VWDMin Trial Summary

This trial is testing whether recombinant von Willebrand factor or tranexamic acid can minimize menorrhagia (heavy bleeding) in women with von Willebrand disease.

Who is the study for?
Women aged 13-45 with mild or moderate von Willebrand disease and heavy menstrual bleeding are eligible. They must have regular periods, no severe allergies to the study drugs, and be willing to use double contraception and avoid certain medications. Those with low platelets, recent surgery, drug treatments that affect immunity or blood clotting, thyroid issues without treatment, iron deficiency not being treated, pregnancy or breastfeeding can't join.Check my eligibility
What is being tested?
The trial is testing recombinant von Willebrand factor (rVWF) against tranexamic acid (TA) over a period of 24 weeks in an outpatient setting. Women will switch between the two treatments for four menstrual cycles to see which one better reduces heavy bleeding.See study design
What are the potential side effects?
Possible side effects include allergic reactions to rVWF or TA. Since both drugs influence blood clotting processes, there may also be risks related to abnormal clot formation or bleeding tendencies.

VWDMin Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged between 13 and 45.
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I have a mild or moderate bleeding disorder.
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I have had very heavy periods recently.
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I am willing to not take aspirin or NSAIDs during the study.
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I am willing to track my bleeding episodes and any medication I take.
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I am willing to visit the clinic 4 times, have my blood tested, and try 2 treatments over 4 menstrual cycles.

VWDMin Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Menstrual Bleeding Severity
Secondary outcome measures
Menstrual bleeding unresponsive to study drugs
Quality of life including depression, wellness, activity
von Willebrand assays, genotype

VWDMin Trial Design

2Treatment groups
Active Control
Group I: Group IActive Control2 Interventions
Subjects randomized to 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, tranexamic acid 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: Group IIActive Control2 Interventions
Group II will receive Arm B, tranexamic acid 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, recombinant von Willebrand factor 40 IU/kg intravenously (IV) infusion on day 1 on each of two menstrual cycles, Cycles 3 and 4.

Find a Location

Who is running the clinical trial?

Margaret RagniLead Sponsor
6 Previous Clinical Trials
32 Total Patients Enrolled
University of North CarolinaOTHER
164 Previous Clinical Trials
1,439,539 Total Patients Enrolled
Duke UniversityOTHER
2,351 Previous Clinical Trials
3,409,417 Total Patients Enrolled

Media Library

Recombinant von Willebrand Factor (Coagulation Factor Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02606045 — Phase 3
Von Willebrand Disease Research Study Groups: Group I, Group II
Von Willebrand Disease Clinical Trial 2023: Recombinant von Willebrand Factor Highlights & Side Effects. Trial Name: NCT02606045 — Phase 3
Recombinant von Willebrand Factor (Coagulation Factor Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02606045 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what purpose is Group I typically assigned?

"Group I treatments are effective for hyperfibrinolysis, hemorrhagic episodes, and von willebrand disease."

Answered by AI

How can I sign up to be a part of this experiment?

"This trial is enrolling 60 participants with von Willebrand disease aged 13 to 45. Applicants must meet the following criteria: Adult females 13-45 years of age., 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"

Answered by AI

Are we still looking for more participants in this trial?

"Recruitment for this trial has ended. Although the listing on clinicaltrials.gov was last updated on September 7th, 2022, the study is no longer looking for patients. There are 27 other studies that von Willebrand disease patients can participate in and 72 trials in total for Group I patients"

Answered by AI

How many individuals are participating in this research project?

"This particular clinical trial is not currently enrolling patients but was last updated on 9/7/2022. There are 27 other trials for von willebrand diseases and 72 studies for Group I that are presently looking for participants."

Answered by AI

What does the FDA think of Group I's drug treatments?

"There is prior clinical data supporting Group I's safety, so it received a score of 3."

Answered by AI

Does this research include minors as participants?

"Eligibility for this study includes participants aged 13 to 45, as specified in the inclusion criteria."

Answered by AI

Are numerous hospitals throughout the U.S. conducting this research?

"There are a total of 19 sites running this study; some notable locations include Syracuse, Orange and Detroit. If you are selected to participate in this trial, it is important to choose the location that is most convenient for you to help minimize travel demands."

Answered by AI

What are some other studies that have used subjects in Group I?

"As of right now, there are 72 ongoing clinical trials worldwide that concern Group I. Out of these research studies, 32 have progressed to Phase 3 testing. The majority of locations for Group I trials are in Kaohsiung City and Yanchao District; however, there are a total of 391 medical centres conducting this type of study."

Answered by AI
~6 spots leftby Mar 2025