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Sponsored by: |
InterMune |
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Information provided by: | InterMune |
ClinicalTrials.gov Identifier: | NCT00075998 |
Condition | Intervention | Phase |
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Idiopathic Pulmonary Fibrosis Lung Disease Pulmonary Fibrosis |
Drug: Interferon gamma-1b ("Actimmune") |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis (The INSPIRE Trial) |
Enrollment: | 826 |
Study Start Date: | December 2003 |
Study Completion Date: | May 2007 |
INSPIRE, the largest and most comprehensive clinical trial ever conducted in IPF, has now completed enrolling patients with mild to moderate IPF.
Eligible patients will receive either Interferon gamma-1b or placebo for a minimum of 2 years.
Ages Eligible for Study: | 40 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
For patients aged < 50 years: At least one of the following diagnostic findings, as well as the absence of any features on specimens resulting from any of these procedures that support an alternative diagnosis, within 48 months before randomization:
IPF disease progression evidenced by one or more of the following within the past year and the absence of evidence of improvement in the past year:
Exclusion criteria:
On a lung transplantation waiting list at time of randomization
Medical Exclusions:
History of unstable or deteriorating cardiac, vascular, or neurologic disease within the previous 6 months, including but not limited to the following:
History of any of the following medical conditions:
Presence of human immunodeficiency virus (HIV) or chronic viral hepatitis
Laboratory Exclusions:
Any of the following liver function test criteria above specified limits:
Total bilirubin > 1.5 x upper limit of normal (ULN); aspartate or alanine aminotransferases (AST/SGOT or ALT/SGPT) > 2 x ULN; alkaline phosphatase > 2 x ULN; or albumin < 3.0 mg/dL
Creatinine > 1.5 x ULN
Concomitant Therapy Exclusions:
The following therapies are excluded within 28 days prior to screening:
Study ID Numbers: | GIPF-007 |
Study First Received: | January 12, 2004 |
Last Updated: | November 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00075998 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Idiopathic Pulmonary Fibrosis IPF Lung |
Interferon Gamma Actimmune INSPIRE 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 |