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Bruton's Tyrosine Kinase Inhibitor

Pirtobrutinib for Immune Thrombocytopenic Purpura

Phase 1 & 2

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have documented history of response, defined as 2 or more platelet counts greater than or equal to 50,000/microliter (μL), 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

Must not have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 16 up to week 40

Summary

"This trial aims to see how well pirtobrutinib is tolerated and what side effects may occur in patients with Primary Immune Thrombocytopenia. It will also investigate the

Who is the study for?

This trial is for individuals with Primary Immune Thrombocytopenia (ITP), a condition where the immune system destroys platelets. Participants must meet specific health criteria, which are not detailed here.

What is being tested?

The study tests pirtobrutinib's tolerability and side effects in phase 1, then compares its effectiveness and safety at various doses to a placebo in phase 2. It involves oral administration of the drug and regular blood tests over up to 16 weeks for phase 1 and an additional 28 weeks for phase 2.

What are the potential side effects?

Specific side effects of pirtobrutinib are not listed but will be monitored throughout phases 1 and 2 of the trial as participants take the medication orally.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My platelet counts improved to 50,000 or more after treatment.

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My ITP has not improved with treatment and no other treatments are likely to help.

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I have been diagnosed with ITP, a condition where my platelet count is low without any other known disease causing it.

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My liver, kidneys, and blood counts are within normal ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have or had blood cancer.

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I have tested positive for hepatitis B.

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I have a serious heart condition.

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I have hepatitis C confirmed by positive tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 16 up to week 40

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 16 up to week 40

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 up to week 40 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1-Dose Limiting Toxicity (DLT) of Pirtobrutinib

Phase 1-Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Phase 1-Number of Participants with Treatment-Related Adverse Events as Assessed by Clinical Lab Tests: Hematology, Clinical Chemistry, Urinalysis, Pregnancy, Hepatitis Serology and Cytomegalovirus (CMV), Human Immunodeficiency Virus (HIV)

+3 more

Secondary study objectives

Phase 1-Evaluate the Extent of Disease Control

Phase 1-Preliminary Efficacy of Pirtobrutinib

Phase 1: Pharmacokinetics (PK) of Pirtobrutinib

+4 more