NCT06173024

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

Post Trial Access for Study SHP677-304: Recombinant Von Willebrand Factor (rVWF) for Adult and Pediatric Subjects With Severe Von Willebrand Disease (VWD)

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Takeda · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

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.

Detailed description

This is a post-trial access program in which the drug being given is called TAK-577. This study will provide access to TAK-577 before marketing authorization for eligible participants with severe VWD who are benefitting from treatment on study SHP677-304 and cannot adequately be treated via the current standard of care and cannot enter a clinical trial. All participants will receive TAK-577 as a sequential intravenous infusion based on their weight. This is a multi-center, international program. Participants will continue treatment until a benefit is no longer derived from the treatment (or treatment is no longer tolerable), the sponsor decision to end the program, the participant chooses to discontinue the treatment, or TAK-577 becomes commercially available for children.

Conditions

• Von Willebrand Disease (VWD)

Interventions

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

Timeline

• First posted: 2023-12-15
• Last updated: 2025-09-03