Teriflunomide Plus High-dose Dexamethasone as First-line Treatment in Newly Diagnosed Primary Immune Thrombocytopenia
Megadott ok: Trial withdrawn due to substantial protocol amendments invalidating the original design. With no participants enrolled, this aligns with WHO-ICTRP guidelines. Recruitment has ceased, and the revised protocol has been re-registered as NCT07065968.
A legfontosabb adatok
- Fázis
- 2. fázis
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
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A vizsgálat adatai
- Ki végzi
- Peking University People's Hospital
- Azonosító
- NCT06176235
- A regiszteradat frissítve
- 2025. augusztus 11.
- Eredeti leírás
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).A teljes eredeti leírásKevesebb
The Combination of Teriflunomide and High-dose Dexamethasone vs High-dose Dexamethasone Alone as First-line Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia (ITP): A Prospective, Multicenter, Randomized Trial
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).
Bevonási feltételek: 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.
Kizáró feltételek: Received first-line and second-line ITP-modifying therapy (any previous dose of corticosteroids or other immune-suppressive agents); Current or recent (<4 weeks before screening) clinically serious viral, bacterial, fungal, or parasitic infection; Active or a history of malignancy; Positive test result for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV); Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit; Pre-existing acute or chronic liver disease, or serum alanine aminotransferase (ALT) greater than 2 times the upper limit of normal (ULN); 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; Pregnancy or lactation; Patients who are deemed unsuitable for the study by the investigator.