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

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:

Interferon alfa-2b 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
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:

Interferon-alpha

Lung Diseases, Interstitial

Interferon Type II

Fibrosis

Hamman-Rich syndrome

Interferons

Pulmonary Fibrosis

Respiratory Tract Diseases

Lung Diseases

Fibrosing alveolitis

Interferon Alfa-2a

Interferon Alfa-2b

Interferon-gamma, Recombinant

Additional relevant MeSH terms:

Anti-Infective Agents

Pathologic Processes

Antineoplastic Agents

Growth Substances

Therapeutic Uses

Physiological Effects of Drugs

Growth Inhibitors

Angiogenesis Modulating Agents

Angiogenesis Inhibitors

Antiviral Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008

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