Treatment of Idiopathic Pulmonary Fibrosis With Thalidomide
NCT00162760 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2010-06-22
Summary
The goal of this study is to determine whether thalidomide can stop the progression of fibrosis in IPF.
The primary objective of this study is to determine the safety, feasibility and efficacy of 400 mg of thalidomide administered daily for one year in patients with idiopathic pulmonary fibrosis (IPF) who have failed or are not candidates for treatment with corticosteroids and/or cytotoxic drugs.
The study population will consist of patients with biopsy-proven moderate to severe IPF who have failed or are not candidates for standard therapy with corticosteroids and/or cytotoxic drugs.
Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
Interventions
- DRUG
-
Thalidomide
Sponsors & Collaborators
-
Celgene Corporation
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Maureen R Horton, M.D. · Johns Hopkins School of Medicine
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-10-31
- Completion
- 2007-07-31
Countries
- United States
Study Locations
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