FindTrial
Sign In

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
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT06173024
Enrollment
Unknown
Registered
2023-12-15
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Von Willebrand Disease (VWD)

Keywords

Drug Therapy

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.

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.

Interventions

BIOLOGICALTAK-577

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

Sponsors

Takeda
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL

Inclusion criteria

1. Participant has completed the treatment period of the SHP677-304 study (at least 12 months on study treatment). 2. Participant had good clinical response to rVWF treatment. 3. Participant does not have access to any comparable or satisfactory alternative replacement therapy available at country level. 4. Participant will be/has been negatively impacted by discontinuation of rVWF. 5. 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).

Exclusion criteria

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

Contacts

Primary ContactTakeda Contact
medinfoUS@takeda.com+1-877-825-3327

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026