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NCT04278924 · ClinicalTrials.gov registry record · Phase 2
A Study of TAK-079 in Adults With Persistent/Chronic Primary Immune Thrombocytopenia
A Phase 2 study of Primary Immune Thrombocytopenia, sponsored by Takeda.
- Completed
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
- 20
- Study locations
NCT04278924: Completed Phase 2 study of Primary Immune Thrombocytopenia, sponsored by Takeda.
NCT04278924 is a Phase 2 study of Primary Immune Thrombocytopenia that has completed, run by Takeda. The registered enrollment target is 41 participants, below the 129-participant average among 4 other Primary Immune Thrombocytopenia trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04278924, a Phase 2 study of Primary Immune Thrombocytopenia, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with the treatment. SAE means any untoward medical occurrence that at any dose: a) results in death; b) is life-threatening; c) requires inpatient hospitalization or prolongation of an existing hospitalization; d) results in persistent or significant disability or incapacity; e) is a congenital
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TAK-079
Study Locations (20)
Other
- University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski EAD - Pleven
- University Mulitiprofile Hospital for Active Treatment Sveti Georgi EAD - Plovdiv
- University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD - Sofia
- Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia - Sofia
- Clinical Hospital Centre Osijek - Osijek
- Klinicki bolnicki centar Zagreb - Zagreb
- University Hospital Merkur - Zagreb
- Onkologische Schwerpunktpraxis Kurfurstendamm - Berlin
Massachusetts
- Massachusetts General Hospital - Boston
- Boston Medical Center - Boston
Sofia-Grad
- Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda - Sofia
- University Multiprofile Hospital for Active Treatment Sofiamed OOD - Sofia
Arizona
- Arizona Clinical Research Center - Hunt - PPDS - Tucson
Florida
- University of Florida - Gainesville
Illinois
- Bleeding and Clotting Disorders Institute - Peoria
North Carolina
- Leo W. Jenkins Cancer Center - Greenville
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2020-11-09 |
| Est. Completion | 2024-04-29 |
| Phase | Phase 2 |
What the finished NCT04278924 record still lists
NCT04278924 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 129-participant average among 4 other Primary Immune Thrombocytopenia trials with a reported enrollment target (68% lower).
The record links to 1 condition, with Primary Immune Thrombocytopenia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04278924 names 20 study sites across 11 states, led by Other, Massachusetts, Sofia-Grad.
Frequently Asked Questions
What is clinical trial NCT04278924 about?
NCT04278924 is a clinical study titled "A Study of TAK-079 in Adults With Persistent/Chronic Primary Immune Thrombocytopenia". 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 c...
What is the current status of trial NCT04278924?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2020-11-09. Estimated completion is 2024-04-29.
What conditions does trial NCT04278924 study?
This clinical trial studies the following conditions: Primary Immune Thrombocytopenia.
What interventions are being tested in trial NCT04278924?
The interventions under investigation include: Placebo (DRUG), TAK-079 (DRUG).
Who is sponsoring clinical trial NCT04278924?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04278924 being conducted?
This trial has 20 study locations across Arizona, Florida, Illinois, Massachusetts, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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