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

This study has been completed.

First Received on October 9, 2002. Last Updated on November 1, 2007 History of Changes

Sponsor:	InterMune
Information provided by:	InterMune
ClinicalTrials.gov Identifier:	NCT00047645

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 III

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:

Genetics Home Reference related topics: idiopathic pulmonary fibrosis

MedlinePlus related topics: Pulmonary Fibrosis

Drug Information available for: Interferon gamma-1b Gamma Rays Interferons

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:

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
Interferon-gamma, Recombinant
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012