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Sponsored by: |
InterMune |
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Information provided by: | InterMune |
ClinicalTrials.gov Identifier: | NCT00076635 |
Open-label therapy will be administered to up to 220 patients, following completion of either InterMune Protocol GIPF-002 Part B or Protocol GIPF-004, to assess the long-term safety of subcutaneous Interferon gamma-1b. The study duration will be 5 years.
Condition | Intervention | Phase |
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Idiopathic Pulmonary Fibrosis Pulmonary Fibrosis Lung Disease |
Drug: Interferon gamma-1b |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | An Open-Label Study of the Safety of Subcutaneous Recombinant Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis |
Enrollment: | 91 |
Study Start Date: | November 2003 |
Study Completion Date: | April 2007 |
Open-label therapy will be administered subcutaneously. Patients enrolled will continue to receive Interferon gamma-1b therapy three times per week and will be evaluated at 6-week intervals. Patients not taking Interferon gamma-1b at enrollment will re-initiate therapy with subcutaneous Interferon gamma-1b under a dose-escalation scheme, reaching full dose after 2 weeks.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Study ID Numbers: | GIPF-006 |
Study First Received: | January 28, 2004 |
Last Updated: | November 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00076635 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Idiopathic Pulmonary Fibrosis IPF Lung |
Actimmune Interferon Gamma InterMune |
Lung Diseases, Interstitial Interferon Type II Respiratory Tract Diseases Fibrosis Idiopathic Pulmonary Fibrosis |
Lung Diseases Interferons Antiviral Agents Pulmonary Fibrosis Interferon-gamma, Recombinant |
Anti-Infective Agents Lung Diseases, Interstitial Interferon Type II Antineoplastic Agents Fibrosis Interferons Pulmonary Fibrosis |
Antiviral Agents Pharmacologic Actions Pathologic Processes Respiratory Tract Diseases Lung Diseases Therapeutic Uses Interferon-gamma, Recombinant |