Teriflunomide Plus High-dose Dexamethasone as First-line Treatment in Newly Diagnosed Primary Immune Thrombocytopenia

• Status: Recruiting
• Trial end date: 2025-05-12
• Target enrollment: 0
• Participant gender: All

Summary

A randomized, open-label, multicenter study to compare 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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University People's Hospital
• Collaborators: Beijing Friendship Hospital; Beijing Hospital; Beijing Luhe Hospital; Beijing Tsinghua Changgeng Hospital; China-Japan Friendship Hospital; Chinese PLA General Hospital; Navy General Hospital, Beijing; Peking University First Hospital; Peking University Third Hospital
• Treatments: Dexamethasone; Teriflunomide

Criteria

Inclusion Criteria:

1. Newly diagnosed, treatment naïve ITP patients

2. Patients with a platelet count <30,000/μL or a platelet count <50,000/μL with bleeding manifestations at the enrollment;

3. Willing and able to sign written informed consent.

Exclusion Criteria:

1. Received first-line and second-line ITP-modifying therapy (any previous dose of corticosteroids or other immune-suppressive agents);

2. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;

3. Active or a history of malignancy;

4. Positive test result for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV);

5. Pregnancy or lactation;

6. Pre-existing acute or chronic liver disease, or serum alanine aminotransferase (ALT) greater than 2 times the upper limit of normal (ULN);

7. Current or recent (<4 weeks before screening) clinically serious viral, bacterial, fungal, or parasitic infection;

8. A known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test;

9. Patients who are deemed unsuitable for the study by the investigator.