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Low-dose Baricitinib Plus Danazol for Steroid-resistant/Relapse Immune Thrombocytopenia

NCT05852847 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2023-06-13

No results posted yet for this study

Summary

This is a prospective, multicenter, randomized, controlled phase 2 trial to compare the efficacy and safety profiles in ITP patients receiving baricitinib plus danazol to those receiving danazol alone.

Conditions

Interventions

DRUG

Baricitinib 2 MG [Olumiant]

Oral baricitinib was given at a dose of 2 mg daily for 6 months. Treatment was discontinued if very severe or life-threatening adverse events developed or at the patients' request.

DRUG

Danazol

Danazol was given at a dose of 200 mg bid for 6 months

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, 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
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-16
Primary Completion
2024-11-30
Completion
2025-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT05852847 on ClinicalTrials.gov