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Sponsored by: |
InterMune |
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Information provided by: | InterMune |
ClinicalTrials.gov Identifier: | NCT00047658 |
Study GIPF-002 is a phase 2 study designed to characterize the biologic and clinical effects of IFN-g 1b. The objective of the Study is to characterize the biologic and clinical effects of IFN-g 1b administered to patients with idiopathic pulmonary fibrosis (IPF). The Study will be conducted at multiple sites and enroll 30 patients with IPF who have failed treatment with corticosteroids.
Condition | Intervention | Phase |
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Idiopathic Pulmonary Fibrosis |
Drug: Interferon-gamma 1b |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Biology, and Clinical Effects of Interferon Gamma-1b Administered Subcutaneously to Patients With IPF Followed by an Open-Label Extension |
Enrollment: | 32 |
Study Start Date: | November 2001 |
Study Completion Date: | May 2003 |
Ages Eligible for Study: | 20 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Male or Female 20-79 years old
Study ID Numbers: | GIPF-002 |
Study First Received: | October 9, 2002 |
Last Updated: | November 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00047658 |
Health Authority: | United States: Food and Drug Administration |
Lung Diseases, Interstitial Interferon Type II Respiratory Tract Diseases Fibrosis Hamman-Rich syndrome |
Lung Diseases Interferons Pulmonary Fibrosis Interferon-gamma, Recombinant |
Anti-Infective Agents Pathologic Processes Antineoplastic Agents |
Therapeutic Uses Antiviral Agents Pharmacologic Actions |