Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Chronic Primary Immune Thrombocytopenia
Study Details
Study Description
Brief Summary
A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients with Chronic Primary Immune Thrombocytopenia
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Orelabrutinib
|
Drug: Qrelabrutinib
Qrelabrutinib once daily (QD)
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Placebo once daily (QD)
|
Outcome Measures
Primary Outcome Measures
- Durable response rate [Throughout the study period, an average of 6 months]
Eligibility Criteria
Criteria
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.
-
In accordance with the diagnosis of chronic (≥ 12 months) ITP
-
Patients who have previously received at least one anti-ITP first-line standard treatment (glucocorticoids and/or intravenous immunoglobulin) cannot maintain efficacy, or relapse, or cannot tolerate standard treatment, or have insufficient response.
-
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.
Exclusion Criteria:
-
Severe hemorrhage occurred within 4 weeks prior to screening.
-
Subjects suffered from severe ITP at screening and were not eligible for participation in this study as judged by the investigator.
-
Subjects had autoimmune systemic diseases other than ITP unless they would not affect the evaluation of the study results in the judgment of the investigator and sponsor medical monitor.
-
Subjects had multiple immune hemocytopenia.
-
Subjects had inherited thrombocytopenia or secondary ITP.
-
Subjects had a history of arterial or venous thromboembolism within 6 months prior to screening.
-
Received prohibited medications within protocol-specified period before the first dose.
-
Received blood transfusion (including platelet transfusion) within 2 weeks prior to the first dose of the investigational drug.
-
Participated in another study of the investigational drug (and/or investigational device) within 30 days or within 5 half-lives prior to screening (whichever is longer), or is currently participating in another study of the investigational drug (and /or investigational device).
-
The last administration of strong CYP3A inhibitors or strong CYP3A inducers (include food, western medicine, traditional Chinese medicine) is within 14 days (or 5 half-lives, whichever is longer) prior to the first dose, or planned to take a drug or food with a strong inhibition or induction of CYP3A during the study period.
-
Received a major surgery (including splenectomy) or trauma (except biopsy) within 28 days prior to the first dose of the investigational drug, or expected to receive a major surgery during the study treatment period.
-
Received splenectomy and had a prior history of overwhelming post-splenectomy infection (OPSI).
-
Had a history of alcohol or drug abuse currently or within the past 1 year, excepting nicotine and caffeine.
-
Received a COVID-19 vaccine, live vaccine, or live-attenuated vaccine within 1 month prior to screening or during the screening period.
-
Previous exposure to BTK inhibitors.
-
Laboratory results did not meet protocol requirements.
-
Pregnant or lactating women.
-
Subjects whose blood cannot be collected, or who had contraindications for blood collection.
-
Other conditions that were not appropriate for participation in the trial as considered by the investigators.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The first affiliated hospital of bengbu medical college | Bengbu | Anhui | China | 233004 |
| 2 | The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | China | 230022 |
| 3 | Beijing CHAO-YANG Hospital Capital Medcal University | Beijing | Beijing | China | 100044 |
| 4 | Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong | China | 510515 |
| 5 | Henan Cancer Hospital | Zhengzhou | Henan | China | 450004 |
| 6 | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China | 450052 |
| 7 | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | China | 430022 |
| 8 | Yichang Central People's Hospital | Yichang | Hubei | China | 443008 |
| 9 | Jiangxi Provincial People's Hospital | Nanchang | Jiangxi | China | 330006 |
| 10 | The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China | 330006 |
| 11 | Qilu hospital of shandong university | Jinan | Shandong | China | 250012 |
| 12 | Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai | China | 200020 |
| 13 | Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences | Tianjin | Tianjin | China | 300020 |
| 14 | The Second Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | China | 650000 |
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-00126