Low-dose Rituximab Regimens in Chinese Adult Patients With Immune Thrombocytopenia

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT01719692
Status
Completed

Conditions

  • Immune Thrombocytopenic Purpura

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

A comparative study with rituximab (100 mg weekly for 4 weeks and 375mg/m2 for once) shows low dose rituximab may be a useful alternative therapy in patients with ITP.The aim of this study is to compare the efficacy and tolerability of two different regimens of low doses rituximab for the treatment of adult patients with ITP.

Key Dates

Start date
Oct 31, 2012
Status verified
Mar 2024
Primary completion
Oct 31, 2015
Completion
Feb 29, 2016

Study Design

Enrollment
100 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab A group
    375mg/m2 for once
  • Active Comparator: Rituximab B group
    100mg/week for four weeks

Primary Outcome Measure

Overall response rate at week 12 [ Time Frame: Patients will be followed for 6 months at least after Rituximab treatment. ]

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