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

This study has been completed.
Sponsor:
Information provided by:
InterMune
ClinicalTrials.gov Identifier:
NCT00047645
First received: October 9, 2002
Last updated: November 1, 2007
Last verified: November 2007
History of Changes
  Purpose

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:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Male or Female, 20-79 years old

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00047645

Locations
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
InterMune
Investigators
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:
lung
IPF

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

ClinicalTrials.gov processed this record on May 16, 2013