← Back to Search

Coagulation Factor Replacement Therapy

rVWF for Von Willebrand Disease

Phase 3

Recruiting

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout the study participation period, up to 3 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I've needed treatment for bleeding more than 3 times in the last year.

Select...

I have been on daily VWF treatment for over a year, as recommended.

Select...

My diagnosis was confirmed through genetic testing.

Select...

I am 12 years or older with a BMI between 15 and 40.

Select...

I have severe von Willebrand disease and need treatment to control bleeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout the study participation period, up to 3 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Spontaneous Annualized Bleeding Rate (ABR)

Secondary outcome measures

Adverse Events (AEs)/Serious Adverse Events (SAEs)

Average Number of Infusions

Categorized Spontaneous Annualized Bleeding Rate (ABR)

+22 more

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).

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baxalta now part of ShireLead Sponsor

110 Previous Clinical Trials

9,033 Total Patients Enrolled

Takeda Development Center Americas, Inc.Industry Sponsor

56 Previous Clinical Trials

11,963 Total Patients Enrolled

Study DirectorStudy DirectorTakeda

1,209 Previous Clinical Trials

489,393 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

Frequently Asked Questions

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

Are patients currently being recruited for this clinical trial?

"The study, which was first advertised on April 1st 2019 and last updated 13 days ago, is looking for participants."

Answered by AI

rFVIII has been found to be safe for patients, correct?

"There is some efficacy data and multiple rounds of safety data, so rFVIII scored a 3 for safety."

Answered by AI

What are rFVIII's primary therapeutic applications?

"rFVIII is an effective medication for treating hemorrhagic episodes, von willebrand disease, and bleeding."

Answered by AI

At how many distinct locations is this clinical trial being conducted?

"There are a number of locations where this study is currently being conducted, these include the Cincinnati Children's Hospital Medical Center in Cincinnati, Rainbow Babies and Children's Hospital in Cleveland, as well as the Medical University of South carolina (MUSC) in Charleston. There are also 9 other centres where this research is taking place."

Answered by AI

What are the desired outcomes of this research?

"The primary goal of this study, which will be assessed over the course of 12 months, is to evaluate the spontaneous annualized bleeding rate (ABR). Secondary objectives include measuring the categorized weekly number of infusions and the total number of infusions during prophylactic treatment with rVWF (vonicog alfa), as well as determining the number of participants who develop neutralizing antibodies to von Willebrand factor (VWF)."

Answered by AI

To what extent has rFVIII been studied in a clinical setting before?

"Currently, there are 9 trials for rFVIII with 5 of them in Phase 3. Although a few of the clinical studies testing rFVIII are based in Dallas, Texas, 126 research centres across the globe are working on this topic."

Answered by AI

To the best of your knowledge, is this a novel clinical trial?

"rFVIII has been the focus of medical research since 2017. The first study, sponsored by Baxalta (now part of Shire), took place that year and involved 34 patients. After this initial Phase 3 drug approval in 2017, there have been 9 active studies conducted across 50 cities in 19 countries."

Answered by AI

How many people are willing to participate in this research?

"That is correct, the trial detailed on clinicaltrials.gov is currently looking for 71 individuals to fill out the study at 9 different locations. The first posting was on April 1st, 2019 with the most recent update happening on April 13th, 2020."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Recombinant Von Willebrand Factor (rVWF) in Pediatric and Adult Participants With Severe Von Willebrand Disease (VWD)

2019. "A Study of Recombinant Von Willebrand Factor (rVWF) in Pediatric and Adult Participants With Severe Von Willebrand Disease (VWD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03879135.

All > Von Willebrand Disease