Teriflunomide plus high-dose dexamethasone versus high-dose dexamethasone alone for adults with newly diagnosed ITP

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label, randomized Phase 2 trial conducted in Beijing that enrolled 132 adults with newly diagnosed primary immune thrombocytopenia. Participants were randomized to receive either teriflunomide combined with high-dose dexamethasone or high-dose dexamethasone alone as first-line therapy. Platelet counts, bleeding symptoms, and other clinical measures were recorded before and after treatment, and adverse events were monitored throughout follow-up. The trial compares efficacy and safety outcomes between the combination and monotherapy groups.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting
• Peking University Insititute of Hematology, Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting
• Peking University Third Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Xiao-Hui Zhang, MD — Peking University Institute of Hematology, Peking University People's Hospital
• Study coordinator: Xiao-Hui Zhang, MD
• Email: zhangxh@bjmu.edu.cn
• Phone: +8613522338836

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Gene therapy for patients with relapsed immune thrombocytopenia

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.