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Sponsors and Collaborators: |
Daniels, Craig E., M.D. Novartis |
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Information provided by: | Daniels, Craig E., M.D. |
ClinicalTrials.gov Identifier: | NCT00131274 |
The purpose of the study is to evaluate the safety and efficacy of Gleevec (imatinib mesylate) in the treatment of idiopathic pulmonary fibrosis (IPF).
Condition | Intervention | Phase |
---|---|---|
Idiopathic Pulmonary Fibrosis Lung Disease Pulmonary Fibrosis |
Drug: Imatinib Mesylate (Gleevec) |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Double-Blind, Placebo-Controlled, Randomized Study of the Efficacy (Gleevec Imatinib Mesylate) in Patients With Idiopathic Pulmonary Fibrosis |
Estimated Enrollment: | 120 |
Study Start Date: | April 2003 |
Estimated Study Completion Date: | August 2007 |
This is a multicenter, double-blind, parallel, placebo-controlled, randomized phase 2 study to evaluate the safety and efficacy of Gleevec (imatinib mesylate) in the treatment of Idiopathic Pulmonary Fibrosis (IPF). One-hundred- twenty patients will be enrolled in the trial in total. Subjects must have a diagnosis made by HRCT showing definite or probable IPF and clinical symptoms consistent with IPF with onset between 3 and 36 months prior to screening. Subjects will be randomly assigned to receive either Gleevec 600 mg orally or placebo, once per day for approximately 2 years. The primary efficacy will be progression defined as a greater than 10% decline in the forced vital capacity or death. Measures of safety will include all randomized patients who receive at least one dose of study medication. All adverse events and serious adverse events will be separately tabulated and mapped to a standard classification system and grouped by body system. Any serious adverse events that occur during the trial and 30 days after the end of therapy will be reported to the FDA within 24 hours and followed to outcome.
Ages Eligible for Study: | 20 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Worsening as demonstrated by any one of the following within the past year:
Diagnosis must be made by (HRCT) showing definite or probable IPF AND either of the following:
Exclusion Criteria:
Study ID Numbers: | CST1571E2401 |
Study First Received: | August 17, 2005 |
Last Updated: | October 4, 2005 |
ClinicalTrials.gov Identifier: | NCT00131274 |
Health Authority: | United States: Food and Drug Administration |
Pulmonary Fibrosis Respiratory Diseases Interstitial Lung Disease Usual Interstitial Pneumonia |
Imatinib Lung Diseases, Interstitial Respiratory Tract Diseases Fibrosis Hamman-Rich syndrome |
Lung Diseases Respiration Disorders Pulmonary Fibrosis Pneumonia |
Pathologic Processes Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |