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

NCT ID: NCT05232149

Last Updated: 2023-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-21
• Study Completion Date: 2024-12-30

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.

Conditions

Primary Immune Thrombocytopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lower Dose

Orelabrutinib is a white, round, uncoated tablet

Group Type: EXPERIMENTAL

Orelabrutinib( lower dose)

Intervention Type: DRUG

Orelabrutinib is a white, round, uncoated tablet, will be taken lower dose QD by patients with persistent or chronic primary immune thrombocytopenia

Higher Dose

Orelabrutinib is a white, round, uncoated tablet

Group Type: EXPERIMENTAL

Orelabrutinib( higher dose)

Intervention Type: DRUG

Orelabrutinib is a white, round, uncoated tablet, will be taken higher dose QD by patients with persistent or chronic primary immune thrombocytopenia

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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.

7. 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

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing InnoCare Pharma Tech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hainan People's Hospital

Haikou, Hainan, China

Site Status: RECRUITING

Henan Tumor Hospital

Zhengzhou, Henan, China

Site Status: RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status: RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status: RECRUITING

Yichang Central People's Hospital

Yichang, Hubei, China

Site Status: RECRUITING

Wuxi People's Hospital

Wuxi, Jiangsu, China

Site Status: RECRUITING

Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Site Status: RECRUITING

First Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status: RECRUITING

QiLu Hospital of Shandong University

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ming Hou, PhD

Role: CONTACT

houming@medmail.com.cn

18560087007

Facility Contacts

Li'e Lin

Role: primary

Hu Zhou

Role: primary

Fang Wang

Role: primary

Heng Mei, PhD

Role: primary

Jingming Guo

Role: primary

Xin Zhou

Role: primary

Zhenyu Li

Role: primary

Ruibin Huang

Role: primary

Ming Hou

Role: primary

References

Yan S, Zhou H, Huang R, Wang F, Mei H, Lin L, Guo J, Zhou X, Li Z, Liu Y, Li S, Zhou W, Hou Y, Hou M. A phase 2 trial of orelabrutinib showing promising efficacy and safety in patients with persistent or chronic primary immune thrombocytopenia. Am J Hematol. 2024 Jul;99(7):1392-1395. doi: 10.1002/ajh.27303. Epub 2024 Mar 28. No abstract available.

Reference Type: DERIVED

PMID: 38546375 (View on PubMed)

Other Identifiers

ICP-CL-00116

Identifier Type: -

Identifier Source: org_study_id