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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05232149
Recruitment Status : Recruiting
First Posted : February 9, 2022
Last Update Posted : January 12, 2023
Sponsor:
Information provided by (Responsible Party):
Beijing InnoCare Pharma Tech Co., Ltd.

Study Description
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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
Primary Immune Thrombocytopenia Drug: Orelabrutinib( lower dose) Drug: Orelabrutinib( higher dose) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Multi-center, Adaptive Phase IIa/IIb Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Persistent or Chronic Primary Immune Thrombocytopenia
Actual Study Start Date : February 21, 2022
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : December 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Proportion of subjects with the platelet count of ≥ 50 × 109/L after 12 weeks of treatment [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 25 weeks ]
  2. Occurrence of treatment emergent adverse events (TEAE) and treatment-related adverse events (TRAE) were evaluated according to severity [ Time Frame: 25 weeks ]

Other Outcome Measures:
  1. Cmax [ Time Frame: 25 weeks ]
    To obtain pharmacokinetic (PK) data of Orelabrutinib include the peak plasma concentration (Cmax)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05232149


Contacts
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Contact: Ming Hou, PhD 18560087007 houming@medmail.com.cn

Locations
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China, Hainan
Hainan People's Hospital Recruiting
HaiKou, Hainan, China, 570100
Contact: Li'e Lin         
China, Henan
Henan Tumor Hospital Recruiting
ZhengZhou, Henan, China, 450000
Contact: Hu Zhou         
The First Affiliated Hospital of Zhengzhou University Recruiting
ZhengZhou, Henan, China, 450000
Contact: Fang Wang         
China, Hubei
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting
WuHan, Hubei, China, 430000
Contact: Heng Mei, PhD         
Yichang Central People's Hospital Recruiting
YiChang, Hubei, China, 443000
Contact: Jingming Guo         
China, Jiangsu
Wuxi People's Hospital Recruiting
WuXi, Jiangsu, China, 214000
Contact: Xin Zhou         
Affiliated Hospital of Xuzhou Medical University Recruiting
XuZhou, Jiangsu, China, 221000
Contact: Zhenyu Li         
China, Jiangxi
First Hospital of Nanchang University Recruiting
NanChang, Jiangxi, China, 330000
Contact: Ruibin Huang         
China, Shandong
QiLu Hospital of Shandong University Recruiting
JiNan, Shandong, China, 250012
Contact: Ming Hou         
Sponsors and Collaborators
Beijing InnoCare Pharma Tech Co., Ltd.
More Information
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Responsible Party: Beijing InnoCare Pharma Tech Co., Ltd.
ClinicalTrials.gov Identifier: NCT05232149    
Other Study ID Numbers: ICP-CL-00116
First Posted: February 9, 2022    Key Record Dates
Last Update Posted: January 12, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beijing InnoCare Pharma Tech Co., Ltd.:
Persistent or chronic
Additional relevant MeSH terms:
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Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
 Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations