A Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Immune Thrombocytopenia
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lower Dose Orelabrutinib is a white, round, uncoated tablet |
Drug: Orelabrutinib( lower dose)
Orelabrutinib is a white, round, uncoated tablet, will be taken lower dose QD by patients with persistent or chronic primary immune thrombocytopenia
|
| Experimental: Higher Dose Orelabrutinib is a white, round, uncoated tablet |
Drug: Orelabrutinib( higher dose)
Orelabrutinib is a white, round, uncoated tablet, will be taken higher dose QD by patients with persistent or chronic primary immune thrombocytopenia
|
Outcome Measures
Primary Outcome Measures
- Proportion of subjects with the platelet count of ≥ 50 × 109/L after 12 weeks of treatment [12 weeks]
Secondary Outcome Measures
- Proportion of subjects who achieve a complete response (CR) over treatment time. CR is defined as a post-treatment platelet count of ≥100 × 109/L [25 weeks]
- Occurrence of treatment emergent adverse events (TEAE) and treatment-related adverse events (TRAE) were evaluated according to severity [25 weeks]
Other Outcome Measures
- Cmax [25 weeks]
To obtain pharmacokinetic (PK) data of Orelabrutinib include the peak plasma concentration (Cmax)
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Males or females aged from 18 to 80 years (including the marginal values).
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With a body weight of ≥ 35 kg at screening.
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Diagnostic criteria:the diagnosis of persistent (3-12 months) or chronic (≥ 12 months) ITP is met
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Patients who have failed at least 1 prior first-line standard therapy for ITP, or who have failed to tolerate a standard therapy.
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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:
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Severe hemorrhage occurred within 4 weeks prior to screening.
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Subjects suffer from severe ITP at screening
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Subjects have other diseases which mention in protocol (e.g.,inflammatory bowel disease)
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Subjects develop intracranial hemorrhage within 6 months prior to screening.
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Active and uncontrollable infection
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Subjects have a history of coagulopathy other than ITP
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Subjects with a history of malignancies.
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History of major organ transplantation or hematopoietic stem cell/bone marrow transplantation.
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Subjects with a known history of hypersensitivity to the investigational drug as described in the Protocol, or any ingredients.
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Subjects with a Medication history and surgical history which mention in protocol
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Subjects do not meet the criterion of the laboratory test in protocol
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 |
| 5 | Yichang Central People's Hospital | YiChang | Hubei | China | 443000 |
| 6 | Wuxi People's Hospital | WuXi | Jiangsu | China | 214000 |
| 7 | Affiliated Hospital of Xuzhou Medical University | XuZhou | Jiangsu | China | 221000 |
| 8 | First Hospital of Nanchang University | NanChang | Jiangxi | China | 330000 |
| 9 | QiLu Hospital of Shandong University | JiNan | Shandong | China | 250012 |
Sponsors and Collaborators
- Beijing InnoCare Pharma Tech Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ICP-CL-00116