Status:
UNKNOWN
A Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Immune Thrombocytopenia
Lead Sponsor:
Beijing InnoCare Pharma Tech Co., Ltd.
Conditions:
Primary Immune Thrombocytopenia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 extens...
Eligibility Criteria
Inclusion
- 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
- Severe hemorrhage occurred within 4 weeks prior to screening.
- Subjects suffer from severe ITP at screening
- Subjects have other diseases which mention in protocol
- Subjects develop intracranial hemorrhage within 6 months prior to screening.
- Active and uncontrollable infection
- Subjects have a history of coagulopathy other than ITP
- Subjects with a history of malignancies.
- History of major organ transplantation or hematopoietic stem cell/bone marrow transplantation.
- Subjects with a known history of hypersensitivity to the investigational drug as described in the Protocol, or any ingredients.
- Subjects with a Medication history and surgical history which mention in protocol
- Subjects do not meet the criterion of the laboratory test in protocol
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
February 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05232149
Start Date
February 21 2022
End Date
December 30 2024
Last Update
January 12 2023
Active Locations (9)
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1
Hainan People's Hospital
Haikou, Hainan, China, 570100
2
Henan Tumor Hospital
Zhengzhou, Henan, China, 450000
3
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
4
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000