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โ† Trials
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A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllEli Lilly and Company
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In plain words

What the trial is, and whether it could suit you

The purpose of the phase 1 part of this study was to evaluate how well pirtobrutinib is tolerated and what side effects may occur. The phase 2 part of the study will further investigate efficacy and safety of multiple pirtobrutinib dosages versus placebo. The study drug will be administered orally in participants with Primary Immune Thrombocytopenia (ITP). Blood tests will be performed to check how much pirtobrutinib gets into the bloodstream and how long it takes the body to eliminate it. The study will last up to approximately 16 weeks for phase 1 dose-escalation and 28 weeks for phase 2 dose-optimization, excluding screening.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Have a diagnosis of primary ITP, defined as isolated thrombocytopenia not associated with another known disease process * Have documented history of response, defined as 2 or more platelet counts greater than or equal to 50,000/microliter (ฮผL), to at least 1 prior line of therapy. Splenectomy is considered a line of therapy * Have relapsed or treatment-resistant primary ITP, with no available therapies known to provide clinical benefit * Have a platelet count less than 30,000/ฮผL on 2 occasions at least 5 days apart in the 15 days before randomization * Have adequate liver, renal, and hematologic functions as defined by a table * Are willing to follow contraception requirements Exclusion Criteria: * Have a history of any thrombotic or embolic event within 12 months before screening * Had a transfusion with blood or blood products or plasmapheresis within 14 days (Phase 1) or within 28 days (Phase 2) of randomization * Have significant cardiovascular disease * Have a diagnosis or history of hematologic malignancy * Have hepatitis B virus (HBV) defined as positive for antigen of hepatitis B (HBsAg) or polymerase chain reaction (PCR) positive for HBV deoxyribonucleic acid (DNA) * Have hepatitis C virus (HCV) defined as positive for anti-HCV antibodies and PCR positive for HCV ribonucleic acid (RNA)
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What it tests

  • Pirtobrutinib
  • Placebo
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Where

43 sites
USC Norris Comprehensive Cancer Center
Los Angeles, United States
Stanford University
Palo Alto, United States
MedStar Georgetown University Hospital
Washington D.C., United States
University of Miami Hospital and Clinics Sylvester Comprehensive Cancer Center
Miami, United States
Bleeding and Clotting Disorders Institute
Peoria, United States
Ochsner Clinic Foundation
New Orleans, United States
Mayo Clinic
Rochester, United States
Texas Oncology - Central South
Austin, United States

โ€ฆand 35 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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