Status:
UNKNOWN
Teriflunomide for Steroid-resistant/Relapse Immune Thrombocytopenia
Lead Sponsor:
Peking University People's Hospital
Conditions:
Immune Thrombocytopenia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Single-arm, open-label, single-center study to evaluate the efficacy and safety of teriflunomide for the treatment of adults with steroid-resistant/relapse immune thrombocytopenia (ITP).
Detailed Description
This is a prospective, single-arm, open-label study of teriflunomide in approximately 40 patients with ITP who have relapsed or have an insufficient response to prior therapies. Teriflunomide is admin...
Eligibility Criteria
Inclusion
- Diagnosis of primary immune thrombocytopenia (ITP) by excluding other supervened causes of thrombocytopenia
- Patients with a platelet count \<30,000/μL or a platelet count \<50,000/μL with bleeding manifestations at the enrollment;
- Patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid tapering or after its discontinuation;
- Willing and able to sign written informed consent.
Exclusion
- Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;
- Secondary immune thrombocytopenia (e.g. patients with HIV, HCV, Helicobacter pylori infection, malignancy, or patients with confirmed autoimmune disease);
- 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 prior to screening) clinically serious viral, bacterial, fungal, or parasitic infection;
- Have evidence of active tuberculosis (TB), or have previously had evidence of active TB and did not receive appropriate and documented treatment, or have had household contact with a person with active TB and did not receive appropriate and documented prophylaxis for TB;
- Patients who are deemed unsuitable for the study by the investigator.
Key Trial Info
Start Date :
December 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06190145
Start Date
December 5 2023
End Date
June 15 2025
Last Update
January 5 2024
Active Locations (1)
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1
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, China