Recruiting

Von Willebrand Factor

Sponsor:

University of Washington

Code:

NCT04146376

Conditions

Von Willebrand Diseases

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Use of a postpartum diary and additional blood draws

VWF replacement therapy with Wilate

Tranexamic acid

Use of a postpartum diary and additional blood draws.

Study Details

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.

Conditions

Von Willebrand Diseases

Study ID

NCT04146376

Start date

Oct 12, 2019

Status verified date

Dec, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

110 participants

Anticipated

Interventions and Outcome Measures

Arms

Non-Corrector

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.

Corrector

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.

Interventions

Use of a postpartum diary and additional blood draws

A diary will be used to capture postpartum hemorrhage (PPH), Wilate and tranexamic acid use, other drug use, bleeding episodes, and treatment schedules.

Several blood draws additional to what is expected for routine clinical care will also be taken.

VWF replacement therapy with Wilate

This study design uses on-label Wilate for VWF replacement therapy for delivery and the postpartum period in VWD patients whose VWF levels are <100% in the third trimester of pregnancy

Tranexamic acid

This study design uses tranexamic acid for prophylaxis for postpartum hemorrhage for all women with VWD

Use of a postpartum diary and additional blood draws.

A diary will be used to capture postpartum hemorrhage (PPH), tranexamic acid use, other drug use, bleeding episodes, and treatment schedules.

Several blood draws additional to what is expected for routine clinical care will also be taken.

Primary outcome measure

  • rate of primary postpartum hemorrhage (PPH) [ Time Frame: within 24 hours postpartum ]

Central Contacts and Locations

Central contacts

Central Study Contact

919-792-3740VIP.Study@ergomedgroup.com

Locations

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Julie Smith

303-724-6187julie.smith@cuanschutz.edu

Principal Investigator:

Genevieve Moyer, MD

Yale University

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Evangelia Louizos

203-843-6358e.louizos@yale.edu

Principal Investigator:

Robert Bona, MD

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Jemima Duroseau, BSN, RN, MPH

305-243-0796jxp431@med.miami.edu

Principal Investigator:

Michael Paidas, MD

Emory University

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Lucy Sanchez

407-879-4446lucy.sanchez@emory.edu

Principal Investigator:

Christine Kempton, MD, MSc

Bleeding & Clotting Disorders Institute

Recruiting

Peoria, Illinois, United States, 61615

Contacts

Jonathan Roberts, MD

309-692-5337jroberts@ilbcdi.org

Principal Investigator:

Jonathan Roberts, MD

Tulane University School of Medicine, Louisiana Center for Bleeding and Clotting Disorders

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Melody Benton, MPH,MAS,CCRP

504-988-3596mbenton@tulane.edu

Principal Investigator:

Maissaa Janbain, MD

The Pennsylvania State University

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Cynthia Campbell-Baird

cbaird@pennstatehealth.psu.edu

Principal Investigator:

Peter Cygan, MD

Vanderbilt University

Recruiting

Nashville, Tennessee, United States, 27232

Contacts

Jadeah Jackson

615-327-7184jadeah.b.jackson@vumc.org

Principal Investigator:

Shannon Walker, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Emily Powers

801-587-0640emily.powers@hsc.utah.edu

Principal Investigator:

Ming Lim, MBBCh, MS

Washington Center for Bleeding Disorders

Recruiting

Seattle, Washington, United States, 98104

Contacts

Sarah Ruuska, MPH

206-689-6193sarah.ruuska@WACBD.org

Principal Investigator:

Allison Wheeler, MD

More Information

Sponsor

University of Washington

Last update posted

Dec 18, 2025

Last verified

Dec, 2025

Keywords

  • von Willebrand Disease
  • von Willebrand Factor
  • postpartum hemorrhage

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Washington on 2025-12-18.