Post Trial Access Program of TAK-577 for Von Willebrand Disease (VWD)

NCT06173024 | Unknown

• 1 other identifier: TAK-577 PTA
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The post-trial access program allows eligible participants to gain access to unlicensed treatment on compassionate grounds. Recombinant von Willebrand factor (rVWF) also known as TAK-577, is a medicine to help treat Von Willebrand Disease (VWD). This post-trial access program enables continued access to children and adults who are benefitting from treatment on study SHP677-304 (NCT03879135) study.

Conditions

Von Willebrand Disease (VWD)

Keywords

Drug Therapy

Interventions

TAK-577 BIOLOGICAL

TAK-577 as IV injection at dose calculated based on the participant's body weight.

Also known as: Recombinant von Willebrand factor (rVWF), Vonvendi, Vonicog alfa, VEYVONDI

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has completed the treatment period of the SHP677-304 study (at least 12 months on study treatment).
• Participant had good clinical response to rVWF treatment.
• Participant does not have access to any comparable or satisfactory alternative replacement therapy available at country level.
• Participant will be/has been negatively impacted by discontinuation of rVWF.
• Participant and/or a parent(s)/legal guardian is informed of the nature of the post-trial access program and can provide written informed consent for themselves or the child to participate (with assent from a child when appropriate) before treatment).

You may not qualify if:

• \. Participants with known hypersensitivity/intolerance to the study drug will not be eligible for this study

Sponsors & Collaborators

• Takeda: lead

Related Links

• To obtain more information about this study, click this link

MeSH Terms

Conditions

von Willebrand Diseases

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Blood Platelet Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Last Updated: September 3, 2025

Record last verified: 2025-09