NCT07065968 The Efficacy and Safety of Combined Teriflunomide and High-dose Dexamethasone in Newly Diagnosed Primary Immune Thrombocytopenia (TEMPO-2)
| NCT ID | NCT07065968 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Peking University People's Hospital |
| Condition | Immune Thrombocytopenia (ITP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 132 participants |
| Start Date | 2025-08-19 |
| Primary Completion | 2027-09-10 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 132 participants in total. It began in 2025-08-19 with a primary completion date of 2027-09-10.
⚠ 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
A multicenter, open-label, randomized study to report the efficacy and safety of teriflunomide plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with newly diagnosed primary immune thrombocytopenia (ITP).
Eligibility Criteria
Inclusion Criteria: 1. Patients aged ≥18 years; 2. Newly diagnosed, treatment naïve ITP patients; 3. Patients with a platelet count \<30 x10\^9/L or a platelet count \<50 x10\^9/L with bleeding manifestations at the enrollment; 4. Willing and able to sign written informed consent. Exclusion Criteria: 1. Secondary ITP such as drug-related thrombocytopenia, viral infection (HIV, hepatitis B virus, or hepatitis C virus); 2. Pre-existing acute or chronic liver disease, or ALT/AST greater than 2 times the upper limit of normal (ULN); 3. Severe cardiac, renal, hepatic, or respiratory insufficiency; 4. Severe immunodeficiency; 5. Pregnancy or lactation; 6. Active or a history of malignancy; 7. Active infection requiring systemic therapy; 8. Myelodysplastic syndrome, aplastic anemia, or myelofibrosis; 9. A known diagnosis of other autoimmune diseases; 10. Patients who are deemed unsuitable for the study by the investigator.
Contact & Investigator
Xiao-Hui Zhang, MD
PRINCIPAL INVESTIGATOR
Peking University Institute of Hematology, Peking University People's Hospital
Frequently Asked Questions
Who can join the NCT07065968 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Immune Thrombocytopenia (ITP). 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 NCT07065968 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07065968 currently recruiting?
Yes, NCT07065968 is actively recruiting participants. Contact the research team at zhangxh@bjmu.edu.cn for enrollment information.
Where is the NCT07065968 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Beijing, China.
Who is sponsoring the NCT07065968 clinical trial?
NCT07065968 is sponsored by Peking University People's Hospital. The principal investigator is Xiao-Hui Zhang, MD at Peking University Institute of Hematology, Peking University People's Hospital. The trial plans to enroll 132 participants.