Clinical Trials in China / NCT07065968
Recruiting
Phase 2
The Efficacy and Safety of Combined Teriflunomide and High-dose Dexamethasone in Newly Diagnosed Primary Immune Thrombocytopenia (TEMPO-2)
NCT07065968 · tracked via the Priya Life Science China tracker
Condition(s) studied
Immune Thrombocytopenia (ITP)
Investigational drug(s) / intervention(s)
Teriflunomide: Teriflunomide 14 mg orally once daily for 24 weeks.
Dexamethasone: Dexamethasone 40 mg orally once daily for four consecutive days.
Study 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
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.
Primary outcome measure(s)
- Sustained response — Week 24
Sustained response was defined as a platelet count ≥ 30 x10\^9/L and at least a 2-fold increase of the baseline count in the absence of bleeding and rescue therapy for at least three of the four visits of the last 8 weeks of treatment.
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | Recruiting |
| Peking University Insititute of Hematology, Peking University People's Hospital | Beijing | Beijing Municipality | Recruiting |
| Peking University Third Hospital | Beijing | Beijing Municipality | Recruiting |
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Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07065968 on ClinicalTrials.gov ↗ ← All trials in China