Chronic Primary Immune Thrombocytopenia (ITP)Phase 3NCT06004856
Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Chronic Primary Immune Thrombocytopenia
A Phase 3 study testing Orelabrutinib in people with Chronic Primary Immune Thrombocytopenia (ITP), run by Beijing InnoCare Pharma Tech Co., Ltd. at 45 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Primary Immune Thrombocytopenia (ITP)
- What is being tested?
- Orelabrutinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 195 participants
- Where
- 45 sitesChina
- Study dates
- 26 Oct 2023to 30 Apr 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Females of childbearing potential must use an effective method of contraception during the screening period, throughout the entire trial, and for 90 days after the last administration of the investigational medicinal product (IMP).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
China45 sites, 45 recruiting
- Recruiting
Beijing CHAO-YANG Hospital Capital Medcal University
Beijing, Beijing Municipality, 100044
Wenming Chen
- Not yet recruiting
Peking university People's Hospital
Beijing, Beijing Municipality, 100044
Xiaohui Zhang
- Recruiting
The first affiliated hospital of bengbu medical college
Bengbu, Anhui, 233004
Feng Zhang
- Not yet recruiting
Xiangya Hospital Central South University
Changsha, Hunan, 410008
Yajing Xu
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610000
Rong Xiao
- Recruiting
Chenzhou First People's Hospital
Chenzhou, Hunan, 423003
Xinquan Liang
- Not yet recruiting
Xinqiao Hospital of Army Medical University
Chongqing, Chongqing Municipality, 400000
Yimei Feng
- Not yet recruiting
Qilu Hospital Of Shandong University Dezhou Hospital
Dezhou, Shandong, 253000
Lin Wang
- Not yet recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Fenge Yang
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Jing Sun
- Recruiting
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Jie Jin
- Recruiting
Zhejiang Provincial Hospital of Chinese Medicine
Hangzhou, Zhejiang, 310000
Baodong Ye
- Not yet recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Wei Wang
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Qingshu Zeng
- Not yet recruiting
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010000
Da Guo
- Recruiting
Qilu hospital of shandong university
Jinan, Shandong, 250012
Ming Hou, PhD, 18560087007, houming@medmail.com.cn
- Recruiting
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650000
Zeping Zhou
- Recruiting
Gansu Provincial Hospital
Lanzhou, Gansu, 730000
Qike Zhang
- Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471000
Ling Qin
- Not yet recruiting
The Affilated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000
Xiaoming Li
- Recruiting
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006
Chenghao Jin
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Ruibin Huang
- Not yet recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000
Rongfu Zhou
- Not yet recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Guangsheng He
- Not yet recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200020
Junmin Li
- Not yet recruiting
The first Hospital of China Medical University
Shenyang, Liaoning, 110002
Xiaojing Yan
- Recruiting
Huazhong University of Science and Technology Union Shenzhen Hospital
Shenzhen, Guangdong, 518052
Zhi Guo
- Recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Jingyu Zhang
- Not yet recruiting
North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei, 063000
Zhenyu Yan
- Recruiting
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020
Lei Zhang
- Not yet recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Rong Fu
- Not yet recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang Uygur Autonomous Region, 830000
Xinhong Guo
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Heng Mei
- Not yet recruiting
Tongji Medical College Of Hust
Wuhan, Hubei, 430030
Dengju Li
- Recruiting
Wuxi People's Hospital
Wuxi, Jiangsu, 214000
Xin Zhou
- Recruiting
Xi'an Central Hospital
Xi’an, Shanxi, 710003
Yanping Song
- Not yet recruiting
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi’an, Shanxi, 710061
Pengcheng He
- Recruiting
Shaanxi Provincial People'S Hospital
Xi’an, Shanxi, 710068
Yi Wang
- Not yet recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361004
Bing Xu
- Not yet recruiting
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361004
Quanyi Lu
- Not yet recruiting
The Second People's Hospital of Yibin
Yibin, Sichuan, 644000
Shihua Huang
- Recruiting
Yichang Central People's Hospital
Yichang, Hubei, 443008
Jingming Guo
- Recruiting
The Central Hospital of Yongzhou
Yongzhou, Hunan, 425006
Shibin Deng
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450004
Hu Zhou
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Fang Wang
About this study
Official title: 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
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
- Being tested
- Orelabrutinib, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrelabrutinibDrug
Orelabrutinib once daily (QD)
PlaceboDrug
Placebo once daily (QD)
| Study group | Role | What they receive |
|---|---|---|
| Orelabrutinib | Experimental | Not described Receives: Drug: Orelabrutinib |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Durable response rate
Measured: Throughout the study period, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start26 Oct 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Primary Immune Thrombocytopenia (ITP)Studies of the same condition, open and under way.
- More trials run by Beijing InnoCare Pharma Tech Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004856
- Sponsor's protocol ID
- ICP-CL-00126
- Status last verified
- May 2024
- First submitted
- 15 Aug 2023
- Last updated
- 13 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06004856
- Acronym / sponsor ID
- ICP-CL-00126
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orelabrutinib | Experimental | Drug: Orelabrutinib |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OrelabrutinibOrelabrutinib once daily (QD) | Drug | Orelabrutinib |
| PlaceboPlacebo once daily (QD) | Drug | Placebo |
Primary outcome
Durable response rate
Time frame: Throughout the study period, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Orelabrutinib in people with Chronic Primary Immune Thrombocytopenia (ITP), run by Beijing InnoCare Pharma Tech Co., Ltd. at 45 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexia Lu (010-66609745, CO_HGRAC@innocarepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Durable response rate (time frame: Throughout the study period, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.