Efficacy of AB1010 in Patients With Systemic Indolent Mastocytosis

Sponsor
AB Science
Study ID
NCT00831974
Phase
PHASE2
Status
Completed

Conditions

  • Mastocytosis

Eligibility Criteria

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

Interventions

Study Details

This is a 12 weeks study aimed at assessing the safety and efficacy of 2 doses of AB1010 in patients suffering from indolent systemic mastocytosis with handicap.

Key Dates

Start date
Oct 31, 2004
Status verified
Dec 2018
Primary completion
Feb 28, 2007

Study Design

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

Arms

  • Experimental: 2
    masitinib (AB1010) 6 mg/kg/day
  • Experimental: 1
    masitinib (AB1010) 3 mg/kg/day

Primary Outcome Measure

Response on: Pruritus score, Number of flush per day, Pollakyuria (on a daily basis), Number of stools per day, QLQ-C30 score, Hamilton Rating Scale for depression [ Time Frame: 12 weeks ]

Related Studies