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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: October 9, 2002
Last updated: November 2, 2007
Last verified: November 2007
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
Idiopathic Pulmonary Fibrosis
Drug: Interferon-gamma 1b
Phase 2

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
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

Resource links provided by NLM:

Further study details as provided by InterMune:

Primary Outcome Measures:
  • 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 ]

Enrollment: 32
Study Start Date: November 2001
Study Completion Date: May 2003
Intervention Details:
    Drug: Interferon-gamma 1b
    200 mcg, SQ, 3x per week

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00047658

United States, California
UCLA, Dept. of Medicine
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Study Director: Williamson Bradford, MD InterMune
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00047658     History of Changes
Other Study ID Numbers: GIPF-002 
Study First Received: October 9, 2002
Last Updated: November 2, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Idiopathic Interstitial Pneumonias
Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Lung Diseases
Lung Diseases, Interstitial
Pathologic Processes
Respiratory Tract Diseases
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on February 11, 2016