Status:
WITHDRAWN
Teriflunomide Plus High-dose Dexamethasone as First-line Treatment in Newly Diagnosed Primary Immune Thrombocytopenia
Lead Sponsor:
Peking University People's Hospital
Collaborating Sponsors:
Beijing Luhe Hospital
Chinese PLA General Hospital
Conditions:
Immune Thrombocytopenia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 treatmen...
Detailed Description
This is a parallel-group, multicenter, randomized controlled trial of 132 adults with ITP in China. Patients were randomized to teriflunomide plus high-dose dexamethasone and high-dose dexamethasone m...
Eligibility Criteria
Inclusion
- Newly diagnosed, treatment naïve ITP patients
- Patients with a platelet count \<30,000/μL or a platelet count \<50,000/μL with bleeding manifestations at the enrollment;
- Willing and able to sign written informed consent.
Exclusion
- Received first-line and second-line ITP-modifying therapy (any previous dose of corticosteroids or other immune-suppressive agents);
- Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;
- Active or a history of malignancy;
- Positive test result for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV);
- Pregnancy or lactation;
- Pre-existing acute or chronic liver disease, or serum alanine aminotransferase (ALT) greater than 2 times the upper limit of normal (ULN);
- Current or recent (\<4 weeks before screening) clinically serious viral, bacterial, fungal, or parasitic infection;
- 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;
- Patients who are deemed unsuitable for the study by the investigator.
Key Trial Info
Start Date :
December 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06176235
Start Date
December 19 2023
End Date
May 12 2025
Last Update
August 11 2025
Active Locations (10)
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1
Beijing Friendship Hospital
Beijing, China
2
Beijing Hospital
Beijing, China
3
Beijing Luhe Hospital
Beijing, China
4
Beijing Tsinghua Changgeng Hospital
Beijing, China