Immune ThrombocytopeniaPhase 1NCT07315373
Optimal Dose of Zanubrutinib to Treat Adult Immune Thrombocytopenia
A Phase 1 study testing Zanubrutinib 80mg/d, High dose dexamethasone and Zanubrutinib 160mg/d in people with Immune Thrombocytopenia, run by Peking University People's Hospital.
Trial summary
The goal of this clinical trial is to find the best dose of zanubrutinib when used together with high-dose dexamethasone for adults who are newly diagnosed with primary immune thrombocytopenia (ITP), and to learn how safe and effective this combination treatment is. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Immune Thrombocytopenia
- What is being tested?
- Zanubrutinib 80mg/d, High dose dexamethasone and Zanubrutinib 160mg/d
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 25 Dec 2025to 30 Jun 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed newly-diagnosed, treatment-naive ITP;
- Platelet counts <30×10^9/L ;
- Platelet counts < 50×10^9/L and significant bleeding symptoms (WHO bleeding scale 2 or above);
- Willing and able to sign written informed consent.
Who cannot join
- Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;
- Received first-line and second-line ITP-specific treatments (eg, steriods, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) ;
- Current HIV infection or hepatitis B virus or hepatitis C virus infections;
- Active infection;
- Maligancy;
- Severe medical condition (lung, hepatic or renal disorder) other than ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia);
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- Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period; a history of clinically significant adverse reactions to previous corticosteroid therapy
- Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test;
- Patients who are deemed unsuitable for the study by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The FIND Study: A Dose-finding Study to Identify the Optimal Dose of Zanubrutinib in Adults With Immune Thrombocytopenia
The goal of this clinical trial is to find the best dose of zanubrutinib when used together with high-dose dexamethasone for adults who are newly diagnosed with primary immune thrombocytopenia (ITP), and to learn how safe and effective this combination treatment is.
- Conditions
- Immune Thrombocytopenia
- Being tested
- Zanubrutinib 80mg/d, High dose dexamethasone, Zanubrutinib 160mg/d, Zanubrutinib 240mg/d
- Keywords
- ITP, zanubrutinib
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zanubrutinib 80mg/dDrug
Zanubrutinib: 80 mg taken orally once daily for 26 weeks
High dose dexamethasoneDrug
Dexamethasone: 40 mg taken orally once daily for 4 consecutive days at the beginning of treatment. A second identical 4-day course may be repeated after 2 weeks if an adequate initial platelet response is not achieved.
Zanubrutinib 160mg/dDrug
Zanubrutinib: 160 mg taken orally once daily for 26 weeks
Zanubrutinib 240mg/dDrug
Zanubrutinib: 240 mg taken orally once daily for 26 weeks
| Study group | Role | What they receive |
|---|---|---|
| Zanubrutinib 80mg/d + Dexamethasone | Experimental | Participants in this arm will receive a combination therapy consisting of:
Zanubrutinib: 80 mg taken orally once daily for 26 weeks. Dexamethasone: 40 mg taken orally once daily for 4 consecutive days at the beginning of treatment. A second identical 4-day course may be repeated after 2 weeks if an adequate initial platelet response is not achieved. Receives: Drug: Zanubrutinib 80mg/d; Drug: High dose dexamethasone |
| Zanubrutinib 160mg/d + Dexamethasone | Experimental | Participants in this arm will receive a combination therapy consisting of:
Zanubrutinib: 160 mg taken orally once daily for 26 weeks. Dexamethasone: 40 mg taken orally once daily for 4 consecutive days at the beginning of treatment. A second identical 4-day course may be repeated after 2 weeks if an adequate initial platelet response is not achieved. Receives: Drug: High dose dexamethasone; Drug: Zanubrutinib 160mg/d |
| Zanubrutinib 240mg/d + Dexamethasone | Experimental | Participants in this arm will receive a combination therapy consisting of:
Zanubrutinib: 240 mg taken orally once daily for 26 weeks. Dexamethasone: 40 mg taken orally once daily for 4 consecutive days at the beginning of treatment. A second identical 4-day course may be repeated after 2 weeks if an adequate initial platelet response is not achieved. Receives: Drug: High dose dexamethasone; Drug: Zanubrutinib 240mg/d |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained response
The maintenance of platelet count ≥ 30 x 10^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 26-week follow-up.
Measured: 26 weeks
Secondary outcomes (8)
Initial Response (R)
Response (R) as platelet count more than 30,000 per cubic millimeter and at least 2-fold increase of the baseline count and absence of bleeding.
Measured: day 14
Initial complete response (CR)
Complete response (CR) was defined as platelet count more than 100,000 per cubic millimeter and absence of bleeding.
Measured: day 14
Time to response
The time from starting treatment to time of achievement of CR or R
Measured: 6 month
Duration of response (DOR)
Duration of response at 26-week follow up
Measured: 26 weeks
Bleeding events
Number of patients with bleeding
Measured: 26 weeks
Adverse events
Number of patients with adverse events
Measured: 26 weeks
Loss of response
Platelet counts below 100 x 109/L or bleeding (from CR) or platelet counts below 30 x 109/L, less than 2-fold increase of baseline platelet count or bleeding (from R)
Measured: 26 weeks
Health related quality of life
Health-related quality of life using the Immune Thrombocytopenic Purpura-Patient Assessment Questionnaire (ITP-PAQ)
Measured: baseline and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start25 Dec 2025 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Hui Zhang, Peking University People's Hospital
- Investigators
- Xiaohui Zhang, Principal investigator, Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315373
- Sponsor's protocol ID
- ITP-Find Study
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The FIND Study: A Dose-finding Study to Identify the Optimal Dose of Zanubrutinib in Adults With Immune Thrombocytopenia
- ClinicalTrials.gov ID
- NCT07315373
- Acronym / sponsor ID
- ITP-Find Study
- Conditions
- Immune Thrombocytopenia
- Keywords
- ITP, zanubrutinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 25 Dec 2025 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 2 Jan 2026 (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 goal of this clinical trial is to find the best dose of zanubrutinib when used together with high-dose dexamethasone for adults who are newly diagnosed with primary immune thrombocytopenia (ITP), and to learn how safe and effective this combination treatment is.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Zanubrutinib 80mg/d + Dexamethasone | Experimental | Drug: Zanubrutinib 80mg/d, Drug: High dose dexamethasoneParticipants in this arm will receive a combination therapy consisting of: Zanubrutinib: 80 mg taken orally once daily for 26 weeks. Dexamethasone: 40 mg taken orally once daily for 4 consecutive days at the beginning of treatment. A second identical 4-day course may be repeated after 2 weeks if an adequate initial platelet response is not achieved. |
| Zanubrutinib 160mg/d + Dexamethasone | Experimental | Drug: High dose dexamethasone, Drug: Zanubrutinib 160mg/dParticipants in this arm will receive a combination therapy consisting of: Zanubrutinib: 160 mg taken orally once daily for 26 weeks. Dexamethasone: 40 mg taken orally once daily for 4 consecutive days at the beginning of treatment. A second identical 4-day course may be repeated after 2 weeks if an adequate initial platelet response is not achieved. |
| Zanubrutinib 240mg/d + Dexamethasone | Experimental | Drug: High dose dexamethasone, Drug: Zanubrutinib 240mg/dParticipants in this arm will receive a combination therapy consisting of: Zanubrutinib: 240 mg taken orally once daily for 26 weeks. Dexamethasone: 40 mg taken orally once daily for 4 consecutive days at the beginning of treatment. A second identical 4-day course may be repeated after 2 weeks if an adequate initial platelet response is not achieved. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed newly-diagnosed, treatment-naive ITP;
- Platelet counts <30×10^9/L ;
- Platelet counts < 50×10^9/L and significant bleeding symptoms (WHO bleeding scale 2 or above);
- Willing and able to sign written informed consent.
Key exclusion criteria (9 listed)
- Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;
- Received first-line and second-line ITP-specific treatments (eg, steriods, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) ;
- Current HIV infection or hepatitis B virus or hepatitis C virus infections;
- Active infection;
- Maligancy;
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 |
|---|---|---|
| Zanubrutinib 80mg/dZanubrutinib: 80 mg taken orally once daily for 26 weeks | Drug | Zanubrutinib 80mg/d + Dexamethasone |
| High dose dexamethasoneDexamethasone: 40 mg taken orally once daily for 4 consecutive days at the beginning of treatment. A second identical 4-day course may be repeated after 2 weeks if an adequate initial platelet response is not achieved. | Drug | Zanubrutinib 160mg/d + Dexamethasone, Zanubrutinib 240mg/d + Dexamethasone, Zanubrutinib 80mg/d + Dexamethasone |
| Zanubrutinib 160mg/dZanubrutinib: 160 mg taken orally once daily for 26 weeks | Drug | Zanubrutinib 160mg/d + Dexamethasone |
| Zanubrutinib 240mg/dZanubrutinib: 240 mg taken orally once daily for 26 weeks | Drug | Zanubrutinib 240mg/d + Dexamethasone |
Primary outcome
Sustained response
Time frame: 26 weeks
The maintenance of platelet count ≥ 30 x 10^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 26-week follow-up.
8 secondary outcomes
Initial Response (R)
Time frame: day 14
Initial complete response (CR)
Time frame: day 14
Time to response
Time frame: 6 month
Duration of response (DOR)
Time frame: 26 weeks
Bleeding events
Time frame: 26 weeks
Adverse events
Time frame: 26 weeks
Loss of response
Time frame: 26 weeks
Health related quality of life
Time frame: baseline and 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Xiaohui Zhang principal investigator
Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zanubrutinib 80mg/d, High dose dexamethasone and Zanubrutinib 160mg/d in people with Immune Thrombocytopenia, run by Peking University People's Hospital.
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 4 inclusion and 9 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: opening soon, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaohui Zhang, MD (8688324577, zhangxh100@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained response (time frame: 26 weeks). 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 2 Jan 2026.