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Low-dose Baricitinib Plus High-dose Dexamethasone for Patients With Newly Diagnosed Immune Thrombocytopenia

NCT05932524 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2023-07-12

No results posted yet for this study

Summary

A randomized, open-label, multicenter, phase 2 trial to compare the efficacy and safety of baricitinib plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with primary immune thrombocytopenia (ITP).

Conditions

Interventions

DRUG

Baricitinib 2 MG

Baricitinib 2 mg q.d., p.o., for 6 consecutive months.

DRUG

Dexamethasone

Dexamethasone 40 mg q.d. for 4 consecutive days (the 4-day course of dexamethasone will be repeated in the case of lack of response by day 10)

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

  • Xiaohui Zhang · 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
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-07
Primary Completion
2024-06-30
Completion
2025-06-30

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 NCT05932524 on ClinicalTrials.gov