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An Adaptive, Open-Label, Dose-Finding, Phase 1/2 Study Investigating the Safety, Pharmacokinetics, and Clinical Activity of PRN1008, an Oral BTK Inhibitor, in Patients with Relapsed Immune Thrombocytopenic Purpura

Clinical Trial Details

The purpose of this clinical research study is explore the effectiveness and safety of PRN1008 treatment in ITP patients who still have low platelet counts despite having used multiple other therapies. 

Key Eligibility: 

Inclusion Criteria 

  • Male or female patients, aged 18 to 80 years old
  • Immune-related ITP
  • Refractory or relapsed patients with no available and approved therapeutic options
  • A history of response to at least one prior line of therapy
  • Female patients who are of reproductive potential must agree for the duration of active treatment in the study to use a highly effective means of contraception

Exclusion Criteria 

  • Pregnant or lactating women
  • History of current, active malignancy requiring or likely to require chemotherapeutic or surgical treatment during the trial, with the exception of non-melanoma skin cancer
  • Immunosuppressant drugs other than corticosteroids
  • Treatment with rituximab or splenectomy 
  • Planned or concomitant use of any anticoagulants and platelet aggregation inhibiting drugs
  • Current drug or alcohol abuse 
  • History of solid organ transplant 
  • Positive screening for HIV, hepatitis B or hepatitis C
  • History of serious infections requiring intravenous therapy
  • Planned surgery in the time frame of the dosing period

Study contact by location

Upper East Side - Manhattan

Contact(s)

Elizabeth Newman
(646) 962-2065
eln9011@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1802018974

ClinicalTrials.gov:

NCT03395210

Sponsor:

PRN1008-010

Status

Open to Enrollment

Age Group

Adult

Sponsor