Rituximab in Auto-Immune Hemolytic Anemia

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT01181154
Phase
PHASE3
Status
Completed

Conditions

  • Warm Autoimmune Hemolytic Anemia

Eligibility Criteria

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

Interventions

Study Details

The hypothesis based on retrospective data is that, the rate of overall response-rate (PR + CR) at 1 year will be much higher in the rituximab arm (80%) than in the placebo arm (20%).Thirty four patients (17 in each arm) will be include (amendment n°6 - 15/10/2013) over a 3 year period (amendment n°3 - 11/12/2012).

Key Dates

Start date
Mar 3, 2011
Status verified
Oct 2017
Primary completion
Jan 8, 2015
Completion
Jan 8, 2016

Study Design

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

Arms

  • Placebo Comparator: equivalent volume total (=1000 ml)
    Placebo : equivalent volume total (=1000 ml)
  • Experimental: rituximab (Mabthera®)
    rituximab (Mabthera®), 1000 mg at day 1 and day 15

Primary Outcome Measure

Overall response rate (complete and partial response) in both arms [ Time Frame: at 1 year ]

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