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

Sponsor:	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:	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 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:

Genetics Home Reference related topics: idiopathic pulmonary fibrosis

MedlinePlus related topics: Breathing Problems 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:

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

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

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 12, 2012