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RECRUITING
NCT07065968
PHASE2

The Efficacy and Safety of Combined Teriflunomide and High-dose Dexamethasone in Newly Diagnosed Primary Immune Thrombocytopenia (TEMPO-2)

Sponsor: Peking University People's Hospital

View on ClinicalTrials.gov

Summary

A multicenter, open-label, randomized study to report the efficacy and safety of teriflunomide plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with newly diagnosed primary immune thrombocytopenia (ITP).

Official title: Teriflunomide and High-dose Dexamethasone vs High-dose Dexamethasone Alone as First-line Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia: A Prospective, Multicenter, Randomized Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2025-08-19

Completion Date

2027-12-30

Last Updated

2025-09-08

Healthy Volunteers

No

Interventions

DRUG

Teriflunomide

Teriflunomide 14 mg orally once daily for 24 weeks.

DRUG

Dexamethasone

Dexamethasone 40 mg orally once daily for four consecutive days.

Locations (3)

Peking University First Hospital

Beijing, Beijing Municipality, China

Peking University Insititute of Hematology, Peking University People's Hospital

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China