A Multicentre Investigation of 2 Cycles Rituximab Compared With Standard Regimen in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia （ITP）

Sponsor
Shandong University
Study ID
NCT02137681
Phase
PHASE3
Status
Withdrawn

Conditions

  • Immune Thrombocytopenia

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab was given intravenously at a dose of 375mg/m(2) weekly for 2 consecutive weeks (Day 1, 8) in 2 cycles arm; or 4 consecutive weeks (Day 1, 8, 15, 22) in standard 4 cycles arm

Study Details

The project was undertaking by Qilu Hospital, Shandong University and other several well-known hospitals in China. In order to report the efficacy and safety of Rituximab in different frequencies for the treatment of adults with steroid-resistant/relapsed immune thrombocytopenia (ITP).

Key Dates

Start date
May 31, 2014
Status verified
May 2014
Primary completion
Jan 31, 2015
Completion
Jan 31, 2016

Study Design

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

Arms

  • Experimental: 2 cycles
    2 cycles RTX
  • Active Comparator: standard 4 cycles
    standard 4 cycles RTX

Primary Outcome Measure

Early Response [ Time Frame: 3 months ]

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