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

Sponsored by:	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

MedlinePlus related topics: Pulmonary Fibrosis

Drug Information available for: Interferons Interferon gamma-1b

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
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

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

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

Keywords provided by InterMune:

lung
IPF

Study placed in the following topic categories:

Lung Diseases, Interstitial
Interferon Type II
Respiratory Tract Diseases
Fibrosis
Hamman-Rich syndrome

Lung Diseases
Interferons
Pulmonary Fibrosis
Interferon-gamma, Recombinant

Additional relevant MeSH terms:

Anti-Infective Agents
Pathologic Processes
Antineoplastic Agents

Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 30, 2009