Baricitinib for Steroid-resistant/Relapse Immune Thrombocytopenia

Sponsor
Peking University People's Hospital
Study ID
NCT05446831
Phase
PHASE2
Status
Unknown

Conditions

  • ITP
  • Immune Thrombocytopenia

Eligibility Criteria

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

Interventions

  • Baricitinib — DRUG
    Oral baricitinib was given at a dose of 4 mg daily. The decision to initiate rescue therapy was made after assessment of the extent of bleeding, patient preferences, lifestyle and activity, the complications of specific therapies, comorbidities that predisposed patients to bleeding and the tolerance of side effects. If a platelet count over 300,000/μL was observed for two consecutive tests at least 2 weeks apart, baricitinib treatment was interrupted.

Study Details

Single-arm, open-label, single-center study to evaluate the efficacy and safety of baricitinib for the treatment of adults with steroid-resistant/relapse immune thrombocytopenia (ITP).

Key Dates

Start date
Jul 13, 2022
Status verified
Sep 2022
Primary completion
Jun 1, 2023
Completion
Dec 1, 2023

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Baricitinib
    Oral baricitinib was given at a dose of 4 mg daily for 6 months. Treatment was 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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