Baricitinib for Steroid-resistant/Relapse Immune Thrombocytopenia
NCT05446831 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2022-09-28
Summary
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).
Conditions
Interventions
- 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.
Sponsors & Collaborators
-
Peking University People's Hospital
lead OTHER
Principal Investigators
-
Xiaohui Zhang, MD · Peking University People's Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-13
- Primary Completion
- 2023-06-01
- Completion
- 2023-12-01
Countries
- China
Study Locations
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