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Clinical trial to compare the efficacy and safety of masitinib and placebo in the treatment of patients with severe indolent or latent systemic mastocytosis with disability, unresponsive to optimal symptomatic treatment.
THE OBJECTIVE OF THIS STUDY IS TO COMPARE THE EFFICACY AND SAFETY OF AN EXPERIMENTAL DRUG, MASITINIB, ADMINISTERED ORALLY AT 3 MG/KG/DAY WITH A SWITCH AFTER 4 WEEKS OF TREATMENT TO 4.5 MG/KG/DAY AND ANOTHER SWITCH AFTER 4 WEEKS OF TREATMENT TO 6 MG/KG/DAY (ALL SWITCHES WILL BE SUBJECT TO TOXICITY MONITORING) VERSUS PLACEBO IN THE TREATMENT OF PATIENTS WITH SEVERE INDOLENT OR LATENT SYSTEMIC MASTOCYTOSIS WITH DISABILITY, UNRESPONSIVE TO SYMPTOMATIC TREATMENT. MASITINIB WILL BE TAKEN TWICE DAILY ORALLY.
- PHASE III, PROSPECTIVE, MULTICENTER, DOUBLE-BLIND, RANDOMIZED (1:1 RANDOMIZATION), PLACEBO-CONTROLLED, PARALLEL-GROUP, DOUBLE-BLIND STUDY WITH A DURATION OF 24 WEEKS WITH THE POSSIBILITY OF EXTENSION TO COMPARE THE EFFICACY AND SAFETY OF MASITINIB AND PLACEBO IN THE TREATMENT OF PATIENTS WITH SEVERE INDOLENT OR LATENT SYSTEMIC MASTOCYTOSIS WITH DISABILITY, UNRESPONSIVE TO OPTIMAL SYMPTOMATIC TREATMENT.
- Code EudraCT: 2016-001447-39
- Protocol number: AB15003
- Promoter: AB Science
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