AVAILABLENot Applicable

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

Plain-language 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.

Who can participate

SexALL

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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).

Trial details

NCT IDNCT06173024

SponsorTakeda

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

Contact for this trial

Takeda Contact

+1-877-825-3327 medinfoUS@takeda.com

View on ClinicalTrials.gov More Von Willebrand Disease (VWD) trials