NCT04146376 Von Willebrand Factor in Pregnancy (VIP) Study
| NCT ID | NCT04146376 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Washington |
| Condition | Von Willebrand Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 110 participants |
| Start Date | 2019-10-12 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 110 participants in total. It began in 2019-10-12 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * von Willebrand Disease (VWD) patients defined prepartum as Type 1 per National Heart, Lung, and Blood Institute (NHLBI) criterion of von Willebrand Factor (VWF) level less than 30 percent, or Type 2, or Type 3 VWD or * A diagnosis of VWD and VWF and Factor VIII (FVIII) levels obtained in gestational weeks 34-38 that determine enrollment in the non-corrector group: * Patients with gestational week 34-38 VWF:Ag, VWF:Act (or VWF:RCo), or FVIII:C less than 100 percent will be enrolled in the non-corrector group. In patients with an isolated VWF:CB type 2 defect, VWF:CB less than 100 percent can also be determined as a non-corrector * Patients with all VWF parameter levels greater than or equal to 100 percent self-corrected at gestational weeks 34-38 will be enrolled in the corrector group Written informed consent from the patient prepartum, before gestational week 39 Exclusion Criteria: * Presence of a clinical contraindication to receive wilate or tranexamic acid, as determined by the health care provider, such as a prior drug reaction * Presence of other concurrent disorder of hemostasis, platelet dysfunction, or collagen disorders * Presence of liver disease or renal disease, clinical suspicion or diagnosis of preeclampsia or eclampsia, HELLP syndrome, TTP, DIC, or other acquired vasculopathy or coagulopathy * Age less than 18 years * Inability of the local laboratory to monitor the VWF laboratory tests needed during the course of treatment to determine Wilate dosing adjustments
Contact & Investigator
Jill M Johnsen, M.D.
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT04146376 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Von Willebrand Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04146376 currently recruiting?
Yes, NCT04146376 is actively recruiting participants. Contact the research team at VIP.Study@ergomedgroup.com for enrollment information.
Where is the NCT04146376 trial being conducted?
This trial is being conducted at Aurora, United States, New Haven, United States, Miami, United States, Atlanta, United States and 7 additional locations.
Who is sponsoring the NCT04146376 clinical trial?
NCT04146376 is sponsored by University of Washington. The principal investigator is Jill M Johnsen, M.D. at University of Washington. The trial plans to enroll 110 participants.