A Study of the Safety and Clinical Effects of Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis (IPF)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00047658
• Date of registration: 09/10/2002
• Prospective Registration: No
• Primary sponsor: InterMune
• Public title: A Study of the Safety and Clinical Effects of Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis (IPF)
• Scientific 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
• Date of first enrolment: November 2001
• Target sample size: 32
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00047658
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Williamson Bradford, MD
• Affiliation: InterMune

Key inclusion & exclusion criteria

Male or Female 20-79 years old



Age minimum: 20 Years
Age maximum: 79 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: Interferon-gamma 1b

Primary Outcome(s)

change in percent predicted FVC, resting arterial blood gas assessment of alveolar-arterial oxygen gradient, percent predicted DLCO, dyspnea scale, baseline dyspnea index/transition dyspnea index [Time Frame: 23 weeks]

Secondary ID(s)

GIPF-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors