Clinical Trial: Efficacy of AB1010 in Patients With Systemic Indolent Mastocytosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase IIa, Open-label, Randomized Study of Oral AB1010 in Patients With Systemic Indolent Mastocytosis With Handicap and Not Bearing Activating Point Mutations in the Phos

Brief Summary: 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.

Detailed Summary:

Efficacy will be assessed based 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

Sponsor: AB Science

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: AFIRMM score, reduction of organ infiltration,level of tryptase, reduction on bio markers (TNFα, eosinophils, histamine levels), pharmacokinetic profile of AB1010 [ Time Frame: 12 weeks ]

Original Secondary Outcome: Same as current

Information By: AB Science

Dates:
Date Received: January 28, 2009
Date Started: October 2004
Date Completion:
Last Updated: August 13, 2013
Last Verified: January 2009