NCT06190145

Teriflunomide for Steroid-resistant/Relapse Immune Thrombocytopenia

A Single-arm, Open-label Phase II Study to Determine the Safety and Efficacy of Teriflunomide in Patients With Steroid-resistant/Relapse Thrombocytopenia

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 administered as 7 mg orally once daily with dose adjustments for 24 weeks. Efficacy and safety outcomes are assessed on scheduled study visits.

Conditions

• Immune Thrombocytopenia

Interventions

Type	Name	Description
DRUG	Teriflunomide	Starting dose of 7 mg once daily. Dose adjustments were made throughout the study based on individual platelet counts.

Timeline

• Start date: 2023-12-05
• Primary completion: 2024-10-15
• Completion: 2025-06-15
• First posted: 2024-01-05
• Last updated: 2024-01-05

Locations

1 site across 1 country: China