Primary Immune ThrombocytopeniaPhase 2NCT05232149
A Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Immune Thrombocytopenia
A Phase 2 study testing Orelabrutinib( lower dose) and Orelabrutinib( higher dose) in people with Primary Immune Thrombocytopenia, run by Beijing InnoCare Pharma Tech Co., Ltd. at 9 sites in China.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Immune Thrombocytopenia
- What is being tested?
- Orelabrutinib( lower dose) and Orelabrutinib( higher dose)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 9 sitesChina
- Study dates
- 21 Feb 2022to 30 Dec 2024
- Phase
- Phase 2
- 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.
- Diagnostic criteria:the diagnosis of persistent (3-12 months) or chronic (≥ 12 months) ITP is met
- Patients who have failed at least 1 prior first-line standard therapy for ITP, or who have failed to tolerate a standard therapy.
- 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.
- 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.
Who cannot join
- Severe hemorrhage occurred within 4 weeks prior to screening.
- Subjects suffer from severe ITP at screening
- Subjects have other diseases which mention in protocol
- Subjects develop intracranial hemorrhage within 6 months prior to screening.
- Active and uncontrollable infection
- Subjects have a history of coagulopathy other than ITP
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- Subjects with a history of malignancies.
- History of major organ transplantation or hematopoietic stem cell/bone marrow transplantation.
- Subjects with a known history of hypersensitivity to the investigational drug as described in the Protocol, or any ingredients.
- Subjects with a Medication history and surgical history which mention in protocol
- Subjects do not meet the criterion of the laboratory test in protocol
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Hainan People's Hospital
Haikou, Hainan, 570100
Li'e Lin
- Recruiting
QiLu Hospital of Shandong University
Jinan, Shandong, 250012
Ming Hou
- Recruiting
First Hospital of Nanchang University
Nanchang, Jiangxi, 330000
Ruibin Huang
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Heng Mei, PhD
- Recruiting
Wuxi People's Hospital
Wuxi, Jiangsu, 214000
Xin Zhou
- Recruiting
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
Zhenyu Li
- Recruiting
Yichang Central People's Hospital
Yichang, Hubei, 443000
Jingming Guo
- Recruiting
Henan Tumor Hospital
Zhengzhou, Henan, 450000
Hu Zhou
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Fang Wang
About this study
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
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
- Being tested
- Orelabrutinib( lower dose), Orelabrutinib( higher dose)
- Keywords
- Persistent or chronic
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orelabrutinib( lower dose)Drug
Orelabrutinib is a white, round, uncoated tablet, will be taken lower dose QD by patients with persistent or chronic primary immune thrombocytopenia
Orelabrutinib( higher dose)Drug
Orelabrutinib is a white, round, uncoated tablet, will be taken higher dose QD by patients with persistent or chronic primary immune thrombocytopenia
| Study group | Role | What they receive |
|---|---|---|
| Lower Dose | Experimental | Orelabrutinib is a white, round, uncoated tablet Receives: Drug: Orelabrutinib( lower dose) |
| Higher Dose | Experimental | Orelabrutinib is a white, round, uncoated tablet Receives: Drug: Orelabrutinib( higher dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with the platelet count of ≥ 50 × 109/L after 12 weeks of treatment
Measured: 12 weeks
Secondary outcomes (2)
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
Measured: 25 weeks
Occurrence of treatment emergent adverse events (TEAE) and treatment-related adverse events (TRAE) were evaluated according to severity
Measured: 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start21 Feb 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Immune ThrombocytopeniaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT05232149
- Sponsor's protocol ID
- ICP-CL-00116
- Status last verified
- Jan 2023
- First submitted
- 20 Dec 2021
- Last updated
- 12 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38546375
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05232149
- Acronym / sponsor ID
- ICP-CL-00116
- Conditions
- Primary Immune Thrombocytopenia
- Keywords
- Persistent or chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 9 Feb 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lower Dose | Experimental | Drug: Orelabrutinib( lower dose)Orelabrutinib is a white, round, uncoated tablet |
| Higher Dose | Experimental | Drug: Orelabrutinib( higher dose)Orelabrutinib is a white, round, uncoated tablet |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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.
- Diagnostic criteria:the diagnosis of persistent (3-12 months) or chronic (≥ 12 months) ITP is met
- Patients who have failed at least 1 prior first-line standard therapy for ITP, or who have failed to tolerate a standard therapy.
Key exclusion criteria (12 listed)
- Severe hemorrhage occurred within 4 weeks prior to screening.
- Subjects suffer from severe ITP at screening
- Subjects have other diseases which mention in protocol
- Subjects develop intracranial hemorrhage within 6 months prior to screening.
- Active and uncontrollable infection
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 |
|---|---|---|
| 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 | Drug | Lower Dose |
| 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 | Drug | Higher Dose |
Primary outcome
Proportion of subjects with the platelet count of ≥ 50 × 109/L after 12 weeks of treatment
Time frame: 12 weeks
2 secondary outcomes
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
Occurrence of treatment emergent adverse events (TEAE) and treatment-related adverse events (TRAE) were evaluated according to severity
Time frame: 25 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Derived from this study: PubMed 38546375Yan 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.
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Orelabrutinib( lower dose) and Orelabrutinib( higher dose) in people with Primary Immune Thrombocytopenia, run by Beijing InnoCare Pharma Tech Co., Ltd. at 9 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 7 inclusion and 12 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 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Ming Hou, PhD (18560087007, houming@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with the platelet count of ≥ 50 × 109/L after 12 weeks of treatment (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05232149, which also lists 1 linked publication.
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 12 Jan 2023.