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

NCT07065968 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2025-09-08

No results posted yet for this study

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).

Conditions

  • Immune Thrombocytopenia (ITP)

Interventions

DRUG

Teriflunomide

Teriflunomide 14 mg orally once daily for 24 weeks.

DRUG

Dexamethasone

Dexamethasone 40 mg orally once daily for four consecutive days.

Sponsors & Collaborators

  • Peking University Health Science Center

    collaborator OTHER

  • Cisen Pharmaceutical CO., LTD.

    collaborator INDUSTRY

  • Peking University People's Hospital

    lead OTHER

Principal Investigators

  • Xiao-Hui Zhang, MD · Peking University Institute of Hematology, Peking University People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-19
Primary Completion
2027-09-10
Completion
2027-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07065968 on ClinicalTrials.gov