ITP - Immune ThrombocytopeniaPhase 2NCT07669675
TPO-RA Plus Baricitinib vs. TPO-RA for ITP
A Phase 2 study testing Baricitinib and TPO-RA in people with ITP - Immune Thrombocytopenia, run by Peking University People's Hospital.
Trial summary
This is a prospective, randomized, controlled trial. ITP patients who failed prior full-does TPO-RA monotheray for 14 days. Patients are randomly assigned at a 1:1 ratio to receive baricitinib plus TPO-RA or TPO-RA alone. Patients are randomly assigned at a 1:1 ratio to receive baricitinib plus TPO-RA or TPO-RA alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ITP - Immune Thrombocytopenia
- What is being tested?
- Baricitinib and TPO-RA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 Aug 2028
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old;
- Patients diagnosed with primary ITP who failed to achieve a response after 14 days of full-dose TPO-RA therapy;
- Patients with baseline platelet count less than 30×10⁹/L, or those with baseline platelet count ranging from 30×10⁹/L to 50×10⁹/L accompanied by clinically significant bleeding (WHO bleeding score ≥2).
Who cannot join
- Pregnant or lactating women, and who were possibly pregnant, planning to become pregnant, or who had partners planning to become pregnant;
- With active malignancy or a history of malignant tumor;
- Having experienced severe bacterial, viral, fungal or parasitic infection within the past 4 weeks;
- With a history of symptomatic herpes zoster infection within 12 weeks prior to screening;
- Active or chronic HBV, HCV or HIV infection;
- Evidence of active tuberculosis; or previous evidence of active tuberculosis without appropriate and documented treatment; or household contact with patients with active tuberculosis without appropriate and documented tuberculosis prophylaxis;
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- Receipt of live vaccines within the past 12 weeks, or planned live vaccination during the study period;
- Prior baricitinib therapy;
- History of solid organ transplant or planned surgery;
- Myelodysplastic syndrome, aplastic anemia or myelofibrosis;
- Patients with other diseases were undergoing treatment with immunosuppressants;
- Clinically significant thromboembolic events within the past 24 weeks, or ongoing anticoagulant treatment, who are deemed ineligible for the study by the investigator;
- History or presence of myocardial infarction, unstable ischemic heart disease, stroke, or NYHA Class IV heart failure;
- History or active manifestations of severe or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, neurological, neuropsychiatric, or other medical conditions that, in the investigator's judgment, could confer unacceptable safety risks with the investigational product or confound the interpretation of study data;
- AST > 2 times the upper limit of normal (ULN), ALT > 2×ULN, TBIL ≥ 1.5×ULN;
- eGFR < 50 mL/min/1.73m²;
- Other patients deemed unsuitable for enrollment in this study by the investigator.
About this study
Official title: TPO-RA Plus Baricitinib vs. TPO-RA in Patients With ITP : A Randomized, Open-label Trial
This is a prospective, randomized, controlled trial. ITP patients who failed prior full-does TPO-RA monotheray for 14 days. Patients are randomly assigned at a 1:1 ratio to receive baricitinib plus TPO-RA or TPO-RA alone. Patients are randomly assigned at a 1:1 ratio to receive baricitinib plus TPO-RA or TPO-RA alone. The primary endpoint was the 14-day overall response rate without any rescue therapy.
Read the detailed description
This is a prospective, randomized, controlled trial.Eligible patients were at least 18 years old, had a diagnosis of primary ITP and did not respond after receiving TPO-RA (hetrombopag or eltrombopag) at the full dose (hetrombopag 7.5mg per day or eltrombopag 75 mg per day) for 14 days (platelet count below 30×10^9/L or a value less than a 2-fold increase from their baseline platelet count). Patients are randomly assigned at a 1:1 ratio to receive baricitinib plus TPO-RA or TPO-RA alone. Both groups will continue their prior full-dose TPO-RA therapy for 14 days (day 1-14), while baricitinib was given orally at a dose of 2 mg twice daily concomitantly in the combination group for 14 days (day 1-14). The primary endpoint was the 14-day overall response rate without bleeding and any rescue therapy. The secondary endpoints included the 28-day overall response rate, 14-day complete response rate, the 28-day complete response rate, time to response, WHO bleeding scores, health-related quality of life, and adverse events.
- Conditions
- ITP - Immune Thrombocytopenia
- Being tested
- Baricitinib, TPO-RA
- Keywords
- immune thrombocytopenia, baricitinib, TPO-RA
- 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.
BaricitinibDrug
Oral baricitinib is given at a dose of 2 mg twice daily for 14 days.
TPO-RADrug
Also called hetrombopag, eltrombopag
Hetrombopag is given at an initial dose of 7.5 mg once daily for 14 days; eltrombopag is given at an initial dose of 75 mg once daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Combined therapy | Experimental | Oral baricitinib is given at a dose of 2 mg twice daily for 14 days (day 1-14); prior full-dose TPO-RA therapy (hetrombopag 7.5mg once daily or eltrombopag 75mg once daily) was continued for 14 days (day 1-14). Receives: Drug: Baricitinib; Drug: TPO-RA |
| Monotherapy | Active comparator | Prior full-dose TPO-RA (hetrombopag 7.5mg once daily or eltrombopag 75mg once daily) was continued. Receives: Drug: TPO-RA |
What is being measured
The primary outcome is the main question the study is designed to answer.
14-day Overall response rate
Overall response was defined as platelet count over 30,000/μL and at least a 2-fold increase of the baseline count in the absence of bleeding and rescue therapy.
Measured: From enrollment to the end of treatment at 14 days
Secondary outcomes (7)
14-day Complete response (CR) rate
Complete response (CR) was defined as platelet count over 100,000/μL and absence of bleeding.
Measured: From enrollment to the end of treatment at 14 days
28-day ovrall response rate
Overall response was defined as platelet count over 30,000/μL and at least a 2-fold increase of the baseline count and absence of bleeding.
Measured: From enrollment to the end of treatment at 28 days
28-day CR rate
Complete response (CR) was defined as platelet count over 100,000/μL and absence of bleeding.
Measured: From enrollment to the end of treatment at 28 days
Time to response (TTR)
The time from treatment initiation to achieve a CR or a R.
Measured: From the start of study treatment (Day 1) up to day 14
Bleeding events
Bleeding was assessed with the WHO bleeding scale (grade 0, no bleeding; grade 1, petechiae; grade 2, mild blood loss; grade 3, gross blood loss; grade 4, debilitating blood loss).
Measured: From the start of study treatment (Day 1) to the end of day 14
Health-related quality of life (HRQoL)
ITP-patient assessment questionnaire was used to assess the HRQoL before and after treatment.
Measured: From the start of study treatment (Day 1) to the end of day 14
AE
Adverse events
Measured: From enrollment to the end of treatment at 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ITP - 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fu Haixia, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669675
- Sponsor's protocol ID
- SEN-TPO
- Status last verified
- Feb 2026
- First submitted
- 20 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TPO-RA Plus Baricitinib vs. TPO-RA in Patients With ITP : A Randomized, Open-label Trial
- ClinicalTrials.gov ID
- NCT07669675
- Acronym / sponsor ID
- SEN-TPO
- Conditions
- ITP - Immune Thrombocytopenia
- Keywords
- immune thrombocytopenia, baricitinib, TPO-RA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 25 Jun 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.
This is a prospective, randomized, controlled trial. ITP patients who failed prior full-does TPO-RA monotheray for 14 days. Patients are randomly assigned at a 1:1 ratio to receive baricitinib plus TPO-RA or TPO-RA alone. Patients are randomly assigned at a 1:1 ratio to receive baricitinib plus TPO-RA or TPO-RA alone. The primary endpoint was the 14-day overall response rate without any rescue therapy.
Detailed description
This is a prospective, randomized, controlled trial.Eligible patients were at least 18 years old, had a diagnosis of primary ITP and did not respond after receiving TPO-RA (hetrombopag or eltrombopag) at the full dose (hetrombopag 7.5mg per day or eltrombopag 75 mg per day) for 14 days (platelet count below 30×10^9/L or a value less than a 2-fold increase from their baseline platelet count). Patients are randomly assigned at a 1:1 ratio to receive baricitinib plus TPO-RA or TPO-RA alone. Both groups will continue their prior full-dose TPO-RA therapy for 14 days (day 1-14), while baricitinib was given orally at a dose of 2 mg twice daily concomitantly in the combination group for 14 days (day 1-14). The primary endpoint was the 14-day overall response rate without bleeding and any rescue therapy. The secondary endpoints included the 28-day overall response rate, 14-day complete response rate, the 28-day complete response rate, time to response, WHO bleeding scores, health-related quality of life, and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined therapy | Experimental | Drug: Baricitinib, Drug: TPO-RAOral baricitinib is given at a dose of 2 mg twice daily for 14 days (day 1-14); prior full-dose TPO-RA therapy (hetrombopag 7.5mg once daily or eltrombopag 75mg once daily) was continued for 14 days (day 1-14). |
| Monotherapy | Active comparator | Drug: TPO-RAPrior full-dose TPO-RA (hetrombopag 7.5mg once daily or eltrombopag 75mg once daily) was continued. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥18 years old;
- Patients diagnosed with primary ITP who failed to achieve a response after 14 days of full-dose TPO-RA therapy;
- Patients with baseline platelet count less than 30×10⁹/L, or those with baseline platelet count ranging from 30×10⁹/L to 50×10⁹/L accompanied by clinically significant bleeding (WHO bleeding score ≥2).
Key exclusion criteria (17 listed)
- Pregnant or lactating women, and who were possibly pregnant, planning to become pregnant, or who had partners planning to become pregnant;
- With active malignancy or a history of malignant tumor;
- Having experienced severe bacterial, viral, fungal or parasitic infection within the past 4 weeks;
- With a history of symptomatic herpes zoster infection within 12 weeks prior to screening;
- Active or chronic HBV, HCV or HIV 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 |
|---|---|---|
| BaricitinibOral baricitinib is given at a dose of 2 mg twice daily for 14 days. | Drug | Combined therapy |
| TPO-RAAlso: hetrombopag, eltrombopagHetrombopag is given at an initial dose of 7.5 mg once daily for 14 days; eltrombopag is given at an initial dose of 75 mg once daily for 14 days | Drug | Combined therapy, Monotherapy |
Primary outcome
14-day Overall response rate
Time frame: From enrollment to the end of treatment at 14 days
Overall response was defined as platelet count over 30,000/μL and at least a 2-fold increase of the baseline count in the absence of bleeding and rescue therapy.
7 secondary outcomes
14-day Complete response (CR) rate
Time frame: From enrollment to the end of treatment at 14 days
28-day ovrall response rate
Time frame: From enrollment to the end of treatment at 28 days
28-day CR rate
Time frame: From enrollment to the end of treatment at 28 days
Time to response (TTR)
Time frame: From the start of study treatment (Day 1) up to day 14
Bleeding events
Time frame: From the start of study treatment (Day 1) to the end of day 14
Health-related quality of life (HRQoL)
Time frame: From the start of study treatment (Day 1) to the end of day 14
AE
Time frame: From enrollment to the end of treatment at 14 days
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 25 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Baricitinib and TPO-RA in people with ITP - 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 3 inclusion and 17 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 25 Jun 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 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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
14-day Overall response rate (time frame: From enrollment to the end of treatment at 14 days). 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 25 Jun 2026.