A Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Immune Thromb… (NCT05232149) | Clinical Trial Compass
UnknownPhase 2
A Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Immune Thrombocytopenia
China30 participantsStarted 2022-02-21
Plain-language summary
The study is designed to be a randomized, open, multi-center, phase IIa/IIb seamless adaptive trial.
Phase IIa: The study consists of a screening period, a core treatment period, an open label extension period, and a safety follow-up period Phase IIb: At present, a preliminary exploratory study (i.e., phase IIa study) will be conducted first. The design of the phase IIb study (including the selection of populations) will be clarified after a relatively clear understanding of the therapeutic effect, value, risks and benefits of the BTK inhibitor for ITP is obtained.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Subjects have had a detailed understanding of the nature, significance, possible benefits, possible inconveniences, and potential risks of the trial, understood the study procedures, and voluntarily signed a written ICF before the study.
✓. Males or females aged from 18 to 80 years (including the marginal values).
✓. With a body weight of ≥ 35 kg at screening.
✓. Diagnostic criteria:the diagnosis of persistent (3-12 months) or chronic (≥ 12 months) ITP is met
✓. Patients who have failed at least 1 prior first-line standard therapy for ITP, or who have failed to tolerate a standard therapy.
✓. Women of childbearing potential must take a complementary barrier method of contraception in combination with a highly effective method of contraception at screening, throughout the trial, and within 90 days after the last dose of the investigational drug.
✓. The mean of two platelet counts is less than 30 × 109/L and no platelet count is greater than 35 × 109/L during the screening visit and/or before the first dose.
Exclusion criteria
What they're measuring
1
Proportion of subjects with the platelet count of ≥ 50 × 109/L after 12 weeks of treatment