Status:
COMPLETED
A Study of TAK-079 in Adults With Persistent/Chronic Primary Immune Thrombocytopenia
Lead Sponsor:
Takeda
Conditions:
Primary Immune Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 TA...
Detailed Description
The drug being tested in this study is called TAK-079. TAK-079 is being tested to treat people who have primary immune thrombocytopenia (ITP). This study will evaluate the safety and biologic activity...
Eligibility Criteria
Inclusion
- Diagnosed with ITP that has persisted for ≥3 months, diagnosed in accordance to The American Society of Hematology 2011 Evidence-based Practice Guideline for Immune Thrombocytopenia or the International Consensus Report on The Investigation and Management of Primary Immune Thrombocytopenia as locally applicable.
- Has a mean platelet count of \<30,000/μL (and individually ≤35,000/μL) on at least 2 measurements at least 1 week apart during screening.
- Diagnosis of ITP supported by a prior response to an ITP therapy (other than a thrombopoietin receptor agonists \[TPO-RA\]) that achieved a platelet count of ≥50,000/μL.
- If receiving standard background treatment for ITP, treatment should be stable in dose and frequency for at least 4 weeks before dosing.
- Permitted standard background treatments may include: 1 oral corticosteroid; ±1 immunosuppressant from the following list: azathioprine, danazol, dapsone, cyclosporine, mycophenolate mofetil, mycophenolate sodium; ±1 TPO-RA (romiplostim, eltrombopag, avatrombopag); ±fostamatinib. Corticosteroids, including dexamethasone, must be given as oral, daily or every-other-day therapy as opposed to pulse therapy.
- The dose of any permitted standard background therapy must be expected to remain stable through the study, unless dose reduction is required because of toxicities.
Exclusion
- Use of anticoagulants or any drug with antiplatelet effect (such as aspirin) within 3 weeks before screening.
- Has a history of any thrombotic or embolic event within 12 months before screening.
- Has a history of splenectomy within 3 months before screening.
- Use of intravenous immunoglobulin (IVIg), subcutaneous immunoglobulin or anti-D immunoglobulin treatment within 4 weeks of screening, or an expectation that any therapy besides the participant's standard background therapies may be used for treatment of thrombocytopenia (e.g., a rescue therapy) between screening and dosing.
- Diagnosed with chronic obstructive pulmonary disease (COPD) or asthma, and a prebronchodilatory forced expiratory volume in 1 second (FEV1) \<50% of predicted normal.
- Use of rituximab or any monoclonal antibody (mAb) for immunomodulation within 4 months before first dosing. Note: Participants with prior exposure to rituximab must have cluster of differentiation (CD) 19 counts within the normal range at screening.
- Use of immunosuppressants (such as cyclophosphamide, vincristine) other than permitted oral immunosuppressants within 6 months before first dosing.
- Has been diagnosed with myelodysplastic syndrome.
- Has received a live vaccine within 4 weeks before screening or has any live vaccine planned during the study.
- 10 Has had an opportunistic infection ≤12 weeks before initial study dosing or is currently undergoing treatment for a chronic opportunistic infection, such as tuberculosis (TB), pneumocystis pneumonia, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria.
Key Trial Info
Start Date :
November 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2024
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04278924
Start Date
November 9 2020
End Date
April 29 2024
Last Update
June 15 2025
Active Locations (55)
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1
Arizona Clinical Research Center - Hunt - PPDS
Tucson, Arizona, United States, 85715
2
University of Florida
Gainesville, Florida, United States, 32610
3
Bleeding and Clotting Disorders Institute
Peoria, Illinois, United States, 61614-3542
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114