NCT07535645 Baricitinib for Post-HSCT Persistent Thrombocytopenia
| NCT ID | NCT07535645 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Peking University People's Hospital |
| Condition | Persistent Thrombocytopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2026-03-09 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 28 participants in total. It began in 2026-03-09 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective, open-label phase 1b/2 clinical trial to explore the safety and efficacy profiles of baricitinib in patients with thrombopoietin-receptor-agonist-refractory persistent thrombocytopenia after allogeneic hematopoietic stem cell transplantation.
Eligibility Criteria
Inclusion Criteria: * Aged 18-70 years; * Underwent allo-HSCT; * Meet the diagnostic criteria for delayed platelet engraftment (DPE) or secondary failure of platelet recovery (SFPR); * Have platelet counts consistently \<20 ×10\^9/L or transfusion-dependent within 14 days prior to enrollment; * Have received adequate corticosteroid and TPO-RA therapy for persistent thrombocytopenia for no less than 4 weeks, with treatment failure or intolerance; * Complete donor chimerism. Exclusion Criteria: * Relapse of hematologic malignancy or MRD positivity; * Active infection; * Active graft-versus-host disease; * Thrombotic microangiopathy; * Primary graft failure or poor graft function; * Presence of other factors that may lead to secondary thrombocytopenia at the time of PT diagnosis; * History of systemic herpes zoster infection within 12 weeks prior to enrollment screening; * Acute or chronic infection with HBV, HCV, or HIV; * Evidence of active tuberculosis, or history of active tuberculosis without documented standard anti-tuberculosis treatment, or close contact with active tuberculosis without documented standard tuberculosis prophylaxis; * Receipt of a live vaccine within 12 weeks prior to enrollment screening, or planned receipt of a live vaccine during the study period; * Clinically significant thromboembolic event within 24 weeks prior to enrollment screening, or current use of anticoagulant medications deemed by the investigator to carry an uncontrollable risk; * Estimated glomerular filtration rate \<50 mL/min/1.73 m\^2; * Severe pre-existing or current conditions involving the cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, nervous, or neuropsychiatric systems, or other severe or unstable illnesses or laboratory abnormalities that will make the study drug unacceptable for the patient or can interfere study data; * Participation in another clinical trial within 30 days prior to enrollment.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07535645 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Persistent Thrombocytopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07535645 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07535645 currently recruiting?
Yes, NCT07535645 is actively recruiting participants. Contact the research team at zpeng702@163.com for enrollment information.
Where is the NCT07535645 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07535645 clinical trial?
NCT07535645 is sponsored by Peking University People's Hospital. The trial plans to enroll 28 participants.