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Masitinib in Severe Indolent or Smoldering Systemic Mastocytosis

NCT00814073 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2019-12-03

No results posted yet for this 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.

Conditions

  • Indolent Systemic Mastocytosis

Interventions

DRUG

Masitinib

Masitinib 6 mg/kg/day

DRUG

Placebo

Matching placebo

OTHER

Best Supportive Care

Optimal concomitant symptomatic treatments. Includes: H1- and H2-antihistamines, proton pump inhibitors (PPI), sodium cromoglicate, antidepressants, leukotriene antagonists, interferon-alpha, 2-CdA, and corticosteroids.

Sponsors & Collaborators

  • AB Science

    lead INDUSTRY

Principal Investigators

  • Olivier Lortholary, MD, PhD · Hôpital Necker, Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2015-11-30
Completion
2015-11-30
FDA Drug
Yes

Countries

  • United States
  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00814073 on ClinicalTrials.gov