Von Willebrand Disease (VWD)NCT06173024
Post Trial Access Program of TAK-577 for Von Willebrand Disease (VWD)
A study testing TAK-577 in people with Von Willebrand Disease (VWD), run by Takeda.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Von Willebrand Disease (VWD)
- What is being tested?
- TAK-577
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 1. Participants with known hypersensitivity/intolerance to the study drug will not be eligible for this study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Post Trial Access for Study SHP677-304: Recombinant Von Willebrand Factor (rVWF) for Adult and Pediatric Subjects With Severe Von Willebrand Disease (VWD)
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.
Read the 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)
- Being tested
- TAK-577
- Keywords
- Drug Therapy
- Medical subject headings
- von Willebrand Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-577Biological
Also called Recombinant von Willebrand factor (rVWF), Vonvendi, Vonicog alfa, VEYVONDI
TAK-577 as IV injection at dose calculated based on the participant's body weight.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Von Willebrand Disease (VWD)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173024
- Sponsor's protocol ID
- TAK-577 PTA
- Status last verified
- Sep 2025
- First submitted
- 7 Dec 2023
- Last updated
- 3 Sep 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Trial Access for Study SHP677-304: Recombinant Von Willebrand Factor (rVWF) for Adult and Pediatric Subjects With Severe Von Willebrand Disease (VWD)
- ClinicalTrials.gov ID
- NCT06173024
- Acronym / sponsor ID
- TAK-577 PTA
- Conditions
- Von Willebrand Disease (VWD)
- Keywords
- Drug Therapy
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- First posted
- 15 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (1 listed)
- 1. Participants with known hypersensitivity/intolerance to the study drug will not be eligible for this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAK-577Also: Recombinant von Willebrand factor (rVWF), Vonvendi, Vonicog alfa, VEYVONDITAK-577 as IV injection at dose calculated based on the participant's body weight. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- To obtain more information about this study, click this linkLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
Questions about this trial
What is this clinical trial studying?
A study testing TAK-577 in people with Von Willebrand Disease (VWD), run by Takeda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.