A Study of TAK-079 in Adults With Persistent/Chronic Primary Immune Thrombocytopenia
About this clinical trial
Primary immune thrombocytopenia (ITP) is a rare disease that results in low levels of platelets - the cells that help blood clot. The main aim of the study is to check for side effects from taking TAK-079 at three different dose levels. Another aim is to learn if TAK-079 can increase the platelet count in people with ITP. In addition to receiving stable background therapy for ITP, participants will receive an injection of either TAK-079 or a placebo once a week for 2 months. A placebo looks like TAK-079 but will not have any medicine in it. After treatment, all participants will be followed-up for another 2 months. Then, participants who received TAK-079 will continue to be followed-up for an extra 4 months. Participants who received the placebo and would like to receive TAK-079 may be able to do this in an extension period in the study.
At a glance
What medical conditions were being studied?
What was the clinical trial testing?
Placebo, TAK-079
How many participants were enrolled?
41
Were placebos part of the clinical trial?
Yes
When was the clinical trial conducted?
Nov 2020 - Apr 2024
How long was participation in the clinical trial?
All participants will be on study for 32 weeks (8-week treatment + 8 weeks Safety Follow-up + 16-week Long-term Follow-up Period)
Key requirements
Sexes
All
Age
18+ Years
Healthy volunteers?
No