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Coagulation Factor

rVWF +/− ADVATE 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
Additional criterion for previously untreated participants: Participant has not received prior VWF coagulation factor replacement therapy
Diagnosis of severe von Willebrand disease (VWD) with specific criteria for Type 1, Type 2A, Type 2B, Type 2N, Type 2M, or Type 3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the study period of approximately 6.5 years
Awards & highlights

Study Summary

This trial will test the effectiveness of a new treatment for von Willebrand Disease in children.

Who is the study for?
Children under 18 with severe hereditary von Willebrand disease (VWD) can join this trial. They must have had at least one bleed requiring treatment in the past year and agree to follow study rules. Girls who can have babies must test negative for pregnancy and use birth control.Check my eligibility
What is being tested?
The trial is testing recombinant von Willebrand Factor (rVWF), alone or with ADVATE, to treat bleeding in kids with VWD. Over 12-18 months, doctors will give treatments based on their usual practice while checking effectiveness and side effects.See study design
What are the potential side effects?
Possible side effects of rVWF include allergic reactions due to mouse or hamster proteins in the drug, risk of blood clots, and general discomforts like headaches or nausea that are common with infusions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have never received VWF coagulation factor replacement therapy.
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I have been diagnosed with severe von Willebrand disease.
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I am younger than 18 years old.
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I am able to have children, not pregnant, and will use birth control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study period of approximately 6.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study period of approximately 6.5 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
Hemostatic Efficacy
Secondary outcome measures
Area Under the Plasma Concentration/Time Curve From 0 to 96 Hours Post-Infusion (AUC0-96h) for Von Willebrand factor: ristocetin cofactor (VWF:Rco), von Willebrand factor: antigen (VWF:Ag) and von Willebrand factor: collagen binding capacity (VWF:CB)
Area Under the Plasma Concentration/Time Curve From 0 to 96 Hours Post-infusion (AUC0-96h) for Factor VIII (FVIII) Activity
Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-inf) for VWF:RCo, VWF:Ag and VWF:CB
+22 more

Side effects data

From 2020 Phase 3 trial • 29 Patients • NCT02973087
20%
Gastroenteritis
20%
Arthralgia
10%
Increased appetite
10%
Oral herpes
10%
Pharyngitis
10%
Upper respiratory tract infection
10%
Urinary tract infection
10%
Rheumatoid arthritis
10%
Flatulence
10%
Diarrhoea
10%
Alanine aminotransferase increased
10%
Neck pain
10%
Rash pruritic
100%
80%
60%
40%
20%
0%
Study treatment Arm
Switch Participants
Prior On-demand Participants

Trial Design

3Treatment groups
Experimental Treatment
Group I: On-demand TreatmentExperimental Treatment2 Interventions
Participants will receive recombinant von Willebrand factor (rVWF) treatment for non-surgical bleeding episodes over a 12 to 18-month period.
Group II: Emergency SurgeryExperimental Treatment2 Interventions
Within 3 hours prior to surgery. Minor surgery: infuse every 12-24 hours for at least 48 hours based on post-operative dosing. Oral Surgery: infuse at least once within first 8-12 hours post-surgery based on post-operative dosing. Major Surgery: infuse every 12-24 hours for at least first 96 hours post-surgery based on post-operative dosing.
Group III: Elective SurgeryExperimental Treatment2 Interventions
12-24 hours prior to surgery and within 3 hours of surgery. Minor surgery: infuse every 12-24 hours for at least 48 hours based on post-operative dosing. Oral Surgery: infuse at least once within first 8-12 hours post-surgery based on post-operative dosing. Major Surgery: infuse every 12-24 hours for at least first 96 hours post-surgery based on post-operative dosing.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Antihemophilic Factor (Recombinant)
2017
Completed Phase 3
~30
von Willebrand factor (Recombinant)
2017
Completed Phase 3
~30

Find a Location

Who is running the clinical trial?

Baxalta now part of ShireLead Sponsor
110 Previous Clinical Trials
9,070 Total Patients Enrolled
Takeda Development Center Americas, Inc.Industry Sponsor
56 Previous Clinical Trials
12,000 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,221 Previous Clinical Trials
499,940 Total Patients Enrolled

Media Library

Antihemophilic Factor (Recombinant) (Coagulation Factor) Clinical Trial Eligibility Overview. Trial Name: NCT02932618 — Phase 3
Von Willebrand Disease Research Study Groups: Elective Surgery, Emergency Surgery, On-demand Treatment
Von Willebrand Disease Clinical Trial 2023: Antihemophilic Factor (Recombinant) Highlights & Side Effects. Trial Name: NCT02932618 — Phase 3
Antihemophilic Factor (Recombinant) (Coagulation Factor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02932618 — Phase 3
~3 spots leftby Jan 2025
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