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

This study has been completed.

First Received: October 9, 2002 Last Updated: November 2, 2007 History of Changes

Sponsored by:	InterMune
Information provided by:	InterMune
ClinicalTrials.gov Identifier:	NCT00047658

Purpose

Study GIPF-002 is a phase 2 study designed to characterize the biologic and clinical effects of IFN-g 1b. The objective of the Study is to characterize the biologic and clinical effects of IFN-g 1b administered to patients with idiopathic pulmonary fibrosis (IPF). The Study will be conducted at multiple sites and enroll 30 patients with IPF who have failed treatment with corticosteroids.

Condition	Intervention	Phase
Idiopathic Pulmonary Fibrosis	Drug: Interferon-gamma 1b	Phase II

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 Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Biology, and Clinical Effects of Interferon Gamma-1b Administered Subcutaneously to Patients With IPF Followed by an Open-Label Extension

Resource links provided by NLM:

MedlinePlus related topics: Breathing Problems Pulmonary Fibrosis

Drug Information available for: Interferon gamma-1b Interferons

U.S. FDA Resources

Further study details as provided by InterMune:

Primary Outcome Measures:

change in percent predicted FVC, resting arterial blood gas assessment of alveolar-arterial oxygen gradient, percent predicted DLCO, dyspnea scale, baseline dyspnea index/transition dyspnea index [ Time Frame: 23 weeks ]

Enrollment:	32
Study Start Date:	November 2001
Study Completion Date:	May 2003

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: NCT00047658

Locations

United States, California
UCLA, Dept. of Medicine
Los Angeles, California, United States, 90095

Sponsors and Collaborators

InterMune

Investigators

Study Director:

Williamson Bradford, MD

InterMune

More Information

No publications provided

Study ID Numbers:	GIPF-002
Study First Received:	October 9, 2002
Last Updated:	November 2, 2007
ClinicalTrials.gov Identifier:	NCT00047658 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Lung Diseases, Interstitial
Interferon Type II
Respiratory Tract Diseases
Fibrosis
Idiopathic Pulmonary Fibrosis

Lung Diseases
Interferons
Antiviral Agents
Pulmonary Fibrosis
Interferon-gamma, Recombinant

Additional relevant MeSH terms:

Anti-Infective Agents
Lung Diseases, Interstitial
Interferon Type II
Antineoplastic Agents
Fibrosis
Interferons
Pulmonary Fibrosis

Antiviral Agents
Pharmacologic Actions
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases
Therapeutic Uses
Interferon-gamma, Recombinant

ClinicalTrials.gov processed this record on July 02, 2009