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Coagulation Factor Replacement Therapy

Corrector for Von Willebrand Disease (VIP Trial)

N/A
Waitlist Available
Led By Jill M Johnsen, M.D.
Research Sponsored by Bloodworks
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours to 6 weeks postpartum
Awards & highlights

Summary

In pregnant women with von Willebrand disease (VWD) who by the third trimester do not have von Willebrand factor (VWF) or factor VIII (FVIII) levels greater than 50-100%, specific guidance is lacking for delivery planning in terms of how high of a VWF level should be achieved to reduce bleeding. This is a prospective, open-label, cohort study in women with VWD using Wilate VWF replacement therapy to maintain trough or minimum VWF levels of 100-150% for delivery and the immediate postpartum period, followed by levels of 50-100% for 5-10 days after delivery, depending upon the route of delivery. The primary objective is to document the rate of primary postpartum hemorrhage (PPH). The secondary objective is to document further effectiveness outcomes and safety.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours to 6 weeks postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours to 6 weeks postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
rate of primary postpartum hemorrhage (PPH)
Secondary study objectives
Postpartum Hemorrhage
Other study objectives
laboratory assessment of efficacy and VWF replacement
occurrence of infusion-related reactions
occurrence of venous or arterial thrombus

Trial Design

2Treatment groups
Experimental Treatment
Group I: Non-CorrectorExperimental Treatment3 Interventions
Patients with gestational week 34-38 von Willebrand factor activity, or von Willebrand factor ristocetin cofactor, or Factor VIII procoagulant activity less than 100 percent will be termed non-correctors. When laboratory monitoring can be performed, patients with an isolated von Willebrand factor collagen binding type 2 defect, von Willebrand factor collagen binding less than 100 percent can also be enrolled and determined as a non-corrector.
Group II: CorrectorExperimental Treatment2 Interventions
Patients with von Willebrand factor parameter levels greater than or equal to 100 percent self-corrected at gestational weeks 34-38 will be termed correctors.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic acid
FDA approved

Find a Location

Who is running the clinical trial?

Mary M. Gooley Hemophilia CenterOTHER
1 Previous Clinical Trials
13 Total Patients Enrolled
OctapharmaIndustry Sponsor
85 Previous Clinical Trials
11,140 Total Patients Enrolled
BloodworksLead Sponsor
11 Previous Clinical Trials
520 Total Patients Enrolled
~19 spots leftby Sep 2025
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