Trials / Completed
CompletedNCT00831974
Efficacy of AB1010 in Patients With Systemic Indolent Mastocytosis
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 Phosphotransferase Domain of c-Kit Such as the Main Mutation Asp-816-Val (D816V)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- AB Science · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 description
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | masitinib (AB1010) | 3 mg/kg/day |
| DRUG | masitinib (AB1010) | 6 mg/kg/day |
Timeline
- Start date
- 2004-10-01
- Primary completion
- 2007-02-01
- First posted
- 2009-01-29
- Last updated
- 2018-12-11
Source: ClinicalTrials.gov record NCT00831974. Inclusion in this directory is not an endorsement.