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Teriflunomide Plus High-dose Dexamethasone as First-line Treatment in Newly Diagnosed Primary Immune Thrombocytopenia

NCT06176235 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-08-11

No results posted yet for this study

Summary

A randomized, open-label, multicenter study to compare 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

Interventions

DRUG

Teriflunomide

Teriflunomide 7 mg orally once daily for 24 weeks. Dose adjustments were made throughout the study based on individual platelet counts.

DRUG

Dexamethasone

Dexamethasone 40 mg orally once daily for four consecutive days (the 4-day course of dexamethasone was repeated in the case of lack of response by day 14).

Sponsors & Collaborators

  • Beijing Luhe Hospital

    collaborator OTHER

  • Chinese PLA General Hospital

    collaborator OTHER

  • Navy General Hospital, Beijing

    collaborator OTHER

  • Beijing Hospital

    collaborator OTHER_GOV

  • Beijing Friendship Hospital

    collaborator OTHER

  • Peking University First Hospital

    collaborator OTHER

  • Peking University Third Hospital

    collaborator OTHER

  • China-Japan Friendship Hospital

    collaborator OTHER

  • Beijing Tsinghua Changgeng Hospital

    collaborator OTHER

  • 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
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-19
Primary Completion
2024-12-12
Completion
2025-05-12

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT06176235 on ClinicalTrials.gov