Woman and Man
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Extract
The objective of this study is to compare the efficacy and safety of masitinib at 6 mg/kg/day to placebo in the treatment of patients with documented Smouldering or Indolent Systemic mastocytosis with severe handicap based on treatment effect on the pruritus score, the number of flushes per week, the HAMD-17 score, and the Fatigue Impact Scale score. Primary endpoint: - Cumulative response by patient*handicap
Inclusion criteria
- Smouldering Systemic, Indolent Systemic or Cutaneous Mastocytosis with handicaps,Tünetekkel járó lappangó szisztémás, indolens szisztémás vagy cutan mastocytosis