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
  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:


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
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

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 September 14, 2014