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Recombinant von Willebrand Factor + Tranexamic Acid for Heavy Menstrual Bleeding (VWDMin Trial)
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.
VWDMin Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowVWDMin Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.VWDMin Trial Design
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Who is running the clinical trial?
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- I have a history of kidney disease.I am willing to not take aspirin or NSAIDs during the study.I am willing to visit the clinic 4 times, have my blood tested, and try 2 treatments over 4 menstrual cycles.I am currently taking blood thinners or anti-inflammatory drugs.I have low iron levels and have not started taking iron supplements.I do not have a bleeding disorder other than von Willebrand disease or a history of blood clots.I haven't had treatments like DDAVP or blood products within the last 5 days.You have never had a bad allergic reaction or severe allergic reaction to rVWF or TA.I am not pregnant, breastfeeding, or have used certain contraceptives in the last 3 months.I am not currently using any immunomodulatory or experimental drugs.I am willing to track my bleeding episodes and any medication I take.I am a woman aged between 13 and 45.I have had surgery within the last 8 weeks.I have a mild or moderate bleeding disorder.I have had very heavy periods recently.
- Group 1: Group I
- Group 2: Group II
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
To what purpose is Group I typically assigned?
"Group I treatments are effective for hyperfibrinolysis, hemorrhagic episodes, and von willebrand disease."
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"
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"
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."
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."
Does this research include minors as participants?
"Eligibility for this study includes participants aged 13 to 45, as specified in the inclusion criteria."
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."
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."
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