Status:
AVAILABLE
Post Trial Access Program of TAK-577 for Von Willebrand Disease (VWD)
Lead Sponsor:
Takeda
Conditions:
Von Willebrand Disease (VWD)
Eligibility:
All Genders
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 medicin...
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 ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 1\. Participants with known hypersensitivity/intolerance to the study drug will not be eligible for this study
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06173024
Last Update
September 3 2025
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