The Study of Different Dose Rituximab in the Treatment of ITP

Sponsor
Shandong University
Study ID
NCT03258866
Phase
PHASE4
Status
Completed

Conditions

  • Immune Thrombocytopenia
  • Purpura, Thrombocytopenic, Idiopathic

Eligibility Criteria

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

Interventions

  • Rituximab — DRUG
    given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22)
  • Rituximab — DRUG
    given with a single dose of 375mg/m2

Study Details

The project was undertaking by Qilu Hospital of Shandong University in China. In order to compare the efficacy, safety and response duration of different dose of rituximab in patients primary immune thrombocytopenia(pITP).

Key Dates

Start date
Jan 1, 2010
Status verified
Aug 2017
Primary completion
Dec 31, 2015
Completion
Dec 31, 2016

Study Design

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

Arms

  • Experimental: group A
    In group A, Rituximab was given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22).
  • Experimental: group B
    In group B, Rituximab was given with a single dose of 375mg/m2

Primary Outcome Measure

Evaluation of platelet response(continuous response rate) [ Time Frame: up to 1 year per subject ]

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