Teriflunomide Plus High-dose Dexamethasone as First-line Treatment in Newly Diagnosed Primary Immune Thrombocytopenia
NCT ID: NCT06176235
Last Updated: 2025-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2023-12-19
2025-05-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Teriflunomide plus Dexamethasone
Oral Teriflunomide was given at a dose of 7 mg once daily for 24 weeks and dexamethasone was given at a dose of 40mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Nonresponsive participants with platelets less than 20 x10\^9/L or with active bleeding were allowed to repeat the 4-day course of dexamethasone treatment.
Teriflunomide
Teriflunomide 7 mg orally once daily for 24 weeks. Dose adjustments were made throughout the study based on individual platelet counts.
Dexamethasone
Dexamethasone 40 mg orally once daily for four consecutive days (the 4-day course of dexamethasone was repeated in the case of lack of response by day 14).
Dexamethasone
Dexamethasone was given at a dose of 40mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of less than 20 x 10\^9/L or with active bleeding were also allowed to repeat the 4-day course of dexamethasone treatment.
Dexamethasone
Dexamethasone 40 mg orally once daily for four consecutive days (the 4-day course of dexamethasone was repeated in the case of lack of response by day 14).
Interventions
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Teriflunomide
Teriflunomide 7 mg orally once daily for 24 weeks. Dose adjustments were made throughout the study based on individual platelet counts.
Dexamethasone
Dexamethasone 40 mg orally once daily for four consecutive days (the 4-day course of dexamethasone was repeated in the case of lack of response by day 14).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Beijing Luhe Hospital
OTHER
Chinese PLA General Hospital
OTHER
Navy General Hospital, Beijing
OTHER
Beijing Hospital
OTHER_GOV
Beijing Friendship Hospital
OTHER
Peking University First Hospital
OTHER
Peking University Third Hospital
OTHER
China-Japan Friendship Hospital
OTHER
Beijing Tsinghua Changgeng Hospital
OTHER
Peking University People's Hospital
OTHER
Responsible Party
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Xiao Hui Zhang
Vice president of Peking Univeristy Institute of Hematology
Principal Investigators
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Xiao-Hui Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University Institute of Hematology, Peking University People's Hospital
Locations
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Beijing Friendship Hospital
Beijing, , China
Beijing Hospital
Beijing, , China
Beijing Luhe Hospital
Beijing, , China
Beijing Tsinghua Changgeng Hospital
Beijing, , China
China-Japan Friendship Hospital
Beijing, , China
Chinese PLA General Hospital
Beijing, , China
Peking University First Hospital
Beijing, , China
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, , China
Peking University Third Hospital
Beijing, , China
The Sixth Medical Center of PLA General Hospital
Beijing, , China
Countries
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Other Identifiers
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PKU-TFITP-03
Identifier Type: -
Identifier Source: org_study_id
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