Using teriflunomide to treat immune thrombocytopenia that doesn't respond to steroids

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, open-label study evaluating the efficacy and safety of teriflunomide in approximately 40 adults with steroid-resistant or relapsed immune thrombocytopenia (ITP). Participants will receive teriflunomide at a dose of 7 mg orally once daily for 24 weeks, with adjustments as needed. The study will assess both efficacy and safety outcomes during scheduled visits throughout the treatment period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Diagnosis of primary immune thrombocytopenia (ITP) by excluding other supervened causes of thrombocytopenia
2. Patients with a platelet count \<30,000/μL or a platelet count \<50,000/μL with bleeding manifestations at the enrollment;
3. 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;
4. Willing and able to sign written informed consent.

Exclusion Criteria:

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;
2. Secondary immune thrombocytopenia (e.g. patients with HIV, HCV, Helicobacter pylori infection, malignancy, or patients with confirmed autoimmune disease);
3. Pregnancy or lactation;
4. Pre-existing acute or chronic liver disease, or serum alanine aminotransferase (ALT) greater than 2 times the upper limit of normal (ULN);
5. Current or recent (\< 4 weeks prior to screening) clinically serious viral, bacterial, fungal, or parasitic infection;
6. 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;
7. Patients who are deemed unsuitable for the study by the investigator.

Where it's running

• Peking University Insititute of Hematology, Peking University People's Hospital
  Beijing, China Recruiting

Study contacts

• Principal investigator: Xiao-Hui Zhang — Peking University Institute of Hematology, Peking University People's Hospital
• Study coordinator: Xiao-Hui Zhang, MD
• Email: zhangxh100@sina.com
• Phone: +8613522338836

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Daratumumab versus rituximab for children with primary immune thrombocytopenia

  This study will test whether daratumumab works better than rituximab to increase platelet counts in children aged 6–17 with primary ITP who did not respond to or relapsed after steroid treatment.

  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin · NCT07362238

• Daratumumab plus rituximab for adults with relapsed or refractory immune thrombocytopenia

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• Daratumumab versus rituximab for adult primary immune thrombocytopenia

  This trial will test whether daratumumab (an anti‑CD38 antibody) works better than rituximab for adults with primary ITP who did not respond to or relapsed after steroid treatment.

  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT07297563

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.