NCT06176911

The Combination of Teriflunomide and Danazol for Steroid-resistant/Relapse Immune Thrombocytopenia

A Multicenter, Open-label, Randomized, Controlled, Phase 2 Trial Comparing the Efficacy and Safety of Teriflunomide Plus Danazol in Patients With Steroid-resistant/Relapse ITP

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy and safety of teriflunomide plus danazol versus danazol in patients with steroid-resistant/relapse ITP

Detailed description

This is a prospective, multicenter, randomized, controlled trial of 124 adult patients with steroid-resistant/relapse ITP in China. Patients were randomized to receive either experimental teriflunomide plus danazol or active comparator danazol monotherapy. Treatment was discontinued if very severe or life-threatening adverse events developed or at the patient's request.

Conditions

• Immune Thrombocytopenia

Interventions

Type	Name	Description
DRUG	Teriflunomide	Starting dose of 7 mg once daily. Dose adjustments are made throughout the study based on individual platelet counts.
DRUG	Danazol	200 mg twice daily.

Timeline

• Start date: 2023-12-05
• Primary completion: 2024-12-30
• Completion: 2025-07-15
• First posted: 2023-12-20
• Last updated: 2023-12-20

Locations

1 site across 1 country: China