TAK-577 PTA
Recruiting
Post Trial Access Program of TAK-577 for Von Willebrand Disease (VWD)
Clinicaltrials.gov
#NCT06173024About this clinical trial
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.
Expanded Access clinical trial.
At a glance
What medical conditions are being studied?
Von Willebrand Disease (VWD)
What is the clinical trial testing?
TAK-577
How long is participation in the clinical trial?
Each participant will be in the program as long as: - there is a benefit in the treatment, or - TAK-577 becomes commercially available for children, or - the program is discontinued by the sponsor, or - the participant chooses to discontinue treatment.
Key requirements
Sexes
All
Age
All
Healthy volunteers?
No
Entry criteria
Must be children/teenagers between 0 and 17 years or adults aged 18 years or older.
Must have responded and completed at least 12 months of treatment in study SHP677-304 (NCT03879135)
Must have no other treatment options available in their country
Additional entry criteria will be discussed with the study doctor.