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NCT00814073 · ClinicalTrials.gov registry record · Phase 3
Masitinib in Severe Indolent or Smoldering Systemic Mastocytosis
A Phase 3 study of Indolent Systemic Mastocytosis, sponsored by AB Science.
- Completed
- Registry status
- Phase 3
- Development phase
- 135
- Enrollment target
- 20
- Study locations
NCT00814073: Completed Phase 3 study of Indolent Systemic Mastocytosis, sponsored by AB Science.
NCT00814073 is a Phase 3 study of Indolent Systemic Mastocytosis that has completed, run by AB Science. The registered enrollment target is 135 participants, below the 302-participant average among 3 other Indolent Systemic Mastocytosis trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00814073, a Phase 3 study of Indolent Systemic Mastocytosis, has completed, sponsored by AB Science.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 135 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this study is to compare the safety and efficacy of masitinib (AB1010) to placebo in patients with mastocytosis with handicap.
Primary Outcome
The prospectively declared primary endpoint (4R75%) was cumulative response in at least one of four severe baseline symptoms of mast cell mediator release (pruritus, flushes, depression, or asthenia). Response was defined as a 75% improvement from baseline for any of these four symptoms. Cumulative response was defined as the number of actual responses between weeks 8 and 24, divided by the total number of possible responses over the same treatment period (ie, with five scheduled visits, each pa
Conditions Studied
Interventions
- DRUG Placebo
- OTHER Best Supportive Care
- DRUG Masitinib
Study Locations (20)
Other
- CHU d'Amiens - Amiens
- Hôpital Avicenne - Bobigny
- CHU de Brest - Brest
- CHU de Caen - Caen
- CHU Clermont Ferrand - Clermont-Ferrand
- Hôpital Claude Huriez - Lille
- CHU Dupuytren - Limoges
- Hôpital Ambroise Paré - Marseille
- Hôpital Nord - Marseille
- Hôpital Central - Nancy
- CHU Hôtel Dieu - Nantes
- Hôpital l'Archet II - Nice
- Hôpital Necker - Paris
- Hôpital Tenon - Paris
- CHU Lyon Sud - Pierre-Bénite
- Centre Hospitalier Lyon Sud - Pierre-Bénite
- CHU Milétrie - Poitiers
- CHU Hôpital Sud - Rennes
California
- UC Davis Health System , Department of Dermatology - Sacramento
Texas
- MD Anderson Cancer Centre - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2008-12 |
| Est. Completion | 2015-11 |
| Phase | Phase 3 |
What the finished NCT00814073 record still lists
NCT00814073 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, below the 302-participant average among 3 other Indolent Systemic Mastocytosis trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Indolent Systemic Mastocytosis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00814073 names 20 study sites across 3 states, led by Other, California, Texas.
Frequently Asked Questions
What is clinical trial NCT00814073 about?
NCT00814073 is a clinical study titled "Masitinib in Severe Indolent or Smoldering Systemic Mastocytosis". The objective of this study is to compare the safety and efficacy of masitinib (AB1010) to placebo in patients with mastocytosis with handicap.
What is the current status of trial NCT00814073?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 135 participants. The study started on 2008-12. Estimated completion is 2015-11.
What conditions does trial NCT00814073 study?
This clinical trial studies the following conditions: Indolent Systemic Mastocytosis.
What interventions are being tested in trial NCT00814073?
The interventions under investigation include: Placebo (DRUG), Best Supportive Care (OTHER), Masitinib (DRUG).
Who is sponsoring clinical trial NCT00814073?
This trial is sponsored by AB Science, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00814073 being conducted?
This trial has 20 study locations across California, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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