Rituximab as Second Line Treatment for ITP

Sponsor
Ostfold Hospital Trust
Study ID
NCT00344149
Phase
PHASE3
Status
Completed

Conditions

  • Immune Thrombocytopenia (ITP)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Immune thrombocytopenic purpura (ITP) is an autoimmune disorder characterized thrombocytopenia. Splenectomy is the standard treatment for patients who fails the first-line treatment: corticosteroid. Rituximab, has recently emerged as a promising treatment for ITP. The aim of the study is to determine whether early treatment with Rituximab can result in durable remissions, and consequently, lead to the avoidance of splenectomy in a significant number of patients.

Key Dates

Start date
Jun 30, 2006
Status verified
Mar 2014
Primary completion
Mar 31, 2014
Completion
Mar 31, 2014

Study Design

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

Arms

  • Experimental: Rituximab
    I.V infusion of Rituximab 375 mg/m2 per week for 4 weeks
  • Placebo Comparator: Placebo
    I.V infusion of NaCl 0.9%

Primary Outcome Measure

The primary endpoint is treatment failure as defined by a composite end point of Splenectomy performed at any time after randomization or Meeting the predefined Criteria for Splenectomy at or after week 12 that is if splenectomy is not performed. [ Time Frame: 1.5 years ]

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