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

Sponsor
Peking University People's Hospital
Study ID
NCT05852847
Phase
PHASE2
Status
Unknown

Conditions

  • Immune Thrombocytopenia

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib 2 MG [Olumiant] — DRUG
    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.
  • Danazol — DRUG
    Danazol was given at a dose of 200 mg bid for 6 months

Study Details

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.

Key Dates

Start date
May 16, 2023
Status verified
Jun 2023
Primary completion
Nov 30, 2024
Completion
May 31, 2025

Study Design

Enrollment
216 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Low-dose baricitinib plus danazol
    Oral baricitinib is given at a dose of 2 mg daily for 6 months. Danazol is given at a dose of 200 mg twice a day for 6 months. Treatment will be discontinued if very severe or life-threatening adverse events developed or at the patients' request.
  • Active Comparator: Danazol
    Danazol is given at a dose of 200 mg twice a day for 6 months. Treatment will be discontinued if very severe or life-threatening adverse events developed or at the patients' request.

Primary Outcome Measure

Durable response [ Time Frame: 6 months ]

Central Contacts

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