- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Expanded Access Type
- Treatment IND/Protocol
Contacts and Locations
Study Contact
- Name: Takeda Contact
- Phone Number: +1-877-825-3327
- Email: medinfoUS@takeda.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
1. Participants with known hypersensitivity/intolerance to the study drug will not be eligible for this study
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Study Director, Takeda
Publications and helpful links
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TAK-577 PTA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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TakedaCompletedVon Willebrand Disease (VWD)Canada
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TakedaCompletedVon Willebrand Disease (VWD)Germany
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OctapharmaRecruitingVWD - Von Willebrand's DiseaseFrance
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VWD Connect FoundationRecruitingVWD - Von Willebrand's DiseaseUnited States
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Baxalta now part of ShireCompletedVon Willebrand DiseaseUnited States, Germany, United Kingdom, Italy, Austria, Canada
Clinical Trials on TAK-577
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The Lowy Medical Research Institute LimitedActive, not recruiting
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Ospedale San RaffaeleUniversity of Rome Tor Vergata; University of Genova; Fondazione G.B. Bietti,...RecruitingMacular Degeneration, Dry | Macular Degeneration, Senile | Laser Burn of Retina | Macular Degeneration IntermediateItaly
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Sun Yat-sen UniversityCompletedAcute Central Serous ChorioretinopathyChina
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Belfast Health and Social Care TrustNorthern Ireland Clinical Trials UnitCompletedDiabetic Macular EdemaUnited Kingdom
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Sun Yat-sen UniversityCompletedDiabetic Macular EdemaChina