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TAK-079-1004
Completed

A Study of TAK-079 in Adults With Persistent/Chronic Primary Immune Thrombocytopenia

Clinicaltrials.gov
#NCT04278924
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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.

ES
IT
UA
8+
Interventional Phase 2 clinical trial.

At a glance

What medical conditions were being studied?

Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)

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

Entry criteria

Both men and women can take part.
Must be of 18 years age or older.
Must have persistent Primary immune thrombocytopenia (ITP) for ≥3 months.
Cannot have history of any thrombotic or embolic event within 12 months before screening.
Cannot have history of splenectomy within 3 months before screening.
Additional entry criteria will be discussed with the study doctor

Study results

Locations