A Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Immune Thrombocytopenia

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Criteria

Inclusion Criteria:

1. 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.

2. Males or females aged from 18 to 80 years (including the marginal values).

3. With a body weight of ≥ 35 kg at screening.

4. Diagnostic criteria:the diagnosis of persistent (3-12 months) or chronic (≥ 12 months) ITP is met

5. Patients who have failed at least 1 prior first-line standard therapy for ITP, or who have failed to tolerate a standard therapy.

6. 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.

Exclusi Criteria:

1. Severe hemorrhage occurred within 4 weeks prior to screening.

2. Subjects suffer from severe ITP at screening

3. Subjects have other diseases which mention in protocol (e.g.,inflammatory bowel disease)

4. Subjects develop intracranial hemorrhage within 6 months prior to screening.

5. Active and uncontrollable infection

6. Subjects have a history of coagulopathy other than ITP

7. Subjects with a history of malignancies.

8. History of major organ transplantation or hematopoietic stem cell/bone marrow transplantation.

9. Subjects with a known history of hypersensitivity to the investigational drug as described in the Protocol, or any ingredients.

10. Subjects with a Medication history and surgical history which mention in protocol

11. Subjects do not meet the criterion of the laboratory test in protocol

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.