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Coagulation Factor Replacement Therapy

rVWF for Von Willebrand Disease

Phase 3
Waitlist Available
Research Sponsored by Baxalta now part of Shire
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant has greater than or equal to (>=) 3 documented spontaneous bleeds (not including menorrhagia) requiring VWF treatment during the past 12 months.
Participant has been receiving OD therapy with VWF products for at least 12 months, and prophylactic treatment is recommended by the investigator.
Must not have
The participant has cervical or uterine conditions causing menorrhagia or metrorrhagia (including infection, dysplasia).
The participant has a medical history of a thromboembolic event.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the study participation period, up to 3 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will test the effectiveness of rVWF in preventing spontaneous bleeds in pediatric and adult patients with von Willebrand Disease.

Who is the study for?
This trial is for pediatric and adult patients with severe Von Willebrand Disease (VWD), specifically types 1, 2A, 2B, 2M, or type 3. Participants must have a history of bleeding episodes requiring treatment and be willing to follow the study protocol. Women who can bear children must test negative for pregnancy and use effective birth control during the study.
What is being tested?
The trial tests rVWF (vonicog alfa) as a preventive treatment over three years to reduce spontaneous bleeding in people with severe VWD. The effectiveness will be measured by counting how many bleeds participants have in the first year on this treatment.
What are the potential side effects?
Possible side effects of rVWF include allergic reactions to its components like mouse or hamster proteins, increased risk of blood clots, and potential infusion-related reactions. Individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've needed treatment for bleeding more than 3 times in the last year.
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I have been on daily VWF treatment for over a year, as recommended.
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My diagnosis was confirmed through genetic testing.
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I am 12 years or older with a BMI between 15 and 40.
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I have severe von Willebrand disease and need treatment to control bleeding.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have conditions like infections or abnormal cell growth in my cervix or uterus causing heavy or irregular bleeding.
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I have had a blood clot in the past.
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My doctor expects I have 15 months or less to live due to my illness.
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I have a Factor VIII inhibitor level of at least 0.4 BU or 0.6 BU, depending on the test used.
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I have not taken any immune system drugs, except for skin creams or nasal sprays, in the last 30 days.
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I have a history of or currently have a VWF inhibitor.
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I have a blood clotting disorder that is not von Willebrand disease.
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My kidney function is impaired with a creatinine level of 2.5 mg/dL or higher.
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I understand the study and am willing to cooperate.
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I am scheduled for surgery.
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I have been diagnosed with serious liver disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study participation period, up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study participation period, up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Spontaneous Annualized Bleeding Rate (ABR)
Secondary study objectives
Adverse Events (AEs)/Serious Adverse Events (SAEs)
Average Number of Infusions
Categorized Spontaneous Annualized Bleeding Rate (ABR)
+22 more

Awards & Highlights

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.

Trial Design

2Treatment groups
Experimental Treatment
Group I: ProphylaxisExperimental Treatment2 Interventions
Participants will receive recombinant von Willebrand factor (rVWF).
Group II: On-DemandExperimental Treatment2 Interventions
Participants will receive recombinant von Willebrand factor (rVWF) (with or without ADVATE).

Find a Location

Who is running the clinical trial?

Baxalta now part of ShireLead Sponsor
110 Previous Clinical Trials
9,027 Total Patients Enrolled
Takeda Development Center Americas, Inc.Industry Sponsor
56 Previous Clinical Trials
10,735 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,276 Previous Clinical Trials
499,239 Total Patients Enrolled

Media Library

rFVIII (Coagulation Factor Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03879135 — Phase 3
Von Willebrand Disease Research Study Groups: Prophylaxis, On-Demand
Von Willebrand Disease Clinical Trial 2023: rFVIII Highlights & Side Effects. Trial Name: NCT03879135 — Phase 3
rFVIII (Coagulation Factor Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03879135 — Phase 3
~2 spots leftby Mar 2025
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