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A Study of TAK-079 in Adults With Persistent/Chronic Primary Immune Thrombocytopenia
NCT04278924 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04278924
The ClinicalTrials.gov registry entry for NCT04278924 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 387 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04278924 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, Massachusetts, Sofia-Grad. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04278924?
The interventions under investigation include: Placebo (DRUG), TAK-079 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04278924?
This trial is sponsored by Takeda, which has 387 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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