A Study of the Safety and Efficacy 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 1, 2007
Last verified: November 2007
Study GIPF-001 is phase 3 study designed to determine the safety and efficacy of IFN-g 1b administered by subcutaneous injection; compared to placebo in patients with IPF who are unresponsive to steroids. 330 patients have been enrolled and were assigned to either a IFN-g 1b group or a placebo group.

Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
Drug: Interferon-gamma 1b
Phase 3

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 Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon-Gamma 1b in Patients With Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:

Further study details as provided by InterMune:

Primary Outcome Measures:
  • Progression-free survival time [ Time Frame: 2 years ]

Enrollment: 330
Study Start Date: April 2000
Study Completion Date: December 2002
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: NCT00047645

United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Study Director: Javier Szwarcberg, MD InterMune
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00047645     History of Changes
Other Study ID Numbers: GIPF-001
Study First Received: October 9, 2002
Last Updated: November 1, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by InterMune:

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 November 27, 2015