A Randomized, Double-Blind, Three-Arm, Phase 3b Study Comparing the Safety and Efficacy of Interferon Gamma-1b With Azathioprine, and Azathioprine Alone in Patients With IPF Receiving Prednisone

This study has been terminated.

( Study design changes were needed based on GIPF-001 results )

First Received: January 21, 2003 Last Updated: November 2, 2007 History of Changes

Sponsored by:	InterMune
Information provided by:	InterMune
ClinicalTrials.gov Identifier:	NCT00052039

Purpose

Study GIPF-003 is a Phase 3b study designed to define better therapeutic use of IFN-gamma 1b in patients wtih IPF. The study will be conducted primarily in Europe and will enroll 210 patients.

Condition	Intervention	Phase
Lung Disease Pulmonary Fibrosis	Drug: interferon-gamma 1b Drug: azathioprine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Three-Arm, Phase IIIb Study Comparing the Safety and Efficacy of Interferon Gamma-1b Alone, IFN-Gamma 1b With Azathioprine, and Azathioprine Alone in Patients With Idiopathic Pulmonary Fibrosis Receiving Prednisone

Resource links provided by NLM:

MedlinePlus related topics: Pulmonary Fibrosis

Drug Information available for: Prednisone Azathioprine sodium salt Interferon gamma-1b Azathioprine Interferons

U.S. FDA Resources

Further study details as provided by InterMune:

Primary Outcome Measures:

This study was terminated prior to enrollment. [ Time Frame: This study was terminated prior to enrollment. ]

Enrollment:	0
Study Start Date:	April 2002
Study Completion Date:	June 2002

Intervention Details:

This study was terminated prior to enrollment.

Eligibility

Ages Eligible for Study:	20 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00052039

Locations

Italy, Orbassano
Ospedale S. Luigi Gonzaga - Regione
Torino, Orbassano, Italy, 10043

Sponsors and Collaborators

InterMune

Investigators

Study Director:

Steven Porter, MD

InterMune

More Information

No publications provided

Study ID Numbers:	GIPF-003
Study First Received:	January 21, 2003
Last Updated:	November 2, 2007
ClinicalTrials.gov Identifier:	NCT00052039 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by InterMune:

idiopathic pulmonary fibrosis

Study placed in the following topic categories:

Antimetabolites
Prednisone
Lung Diseases, Interstitial
Immunologic Factors
Interferon Type II
Fibrosis
Interferons
Antiviral Agents

Pulmonary Fibrosis
Immunosuppressive Agents
Azathioprine
Respiratory Tract Diseases
Lung Diseases
Idiopathic Pulmonary Fibrosis
Antirheumatic Agents
Interferon-gamma, Recombinant

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Lung Diseases, Interstitial
Antimetabolites, Antineoplastic
Immunologic Factors
Interferon Type II
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Fibrosis
Physiological Effects of Drugs
Interferons

Antiviral Agents
Immunosuppressive Agents
Pulmonary Fibrosis
Pharmacologic Actions
Pathologic Processes
Azathioprine
Respiratory Tract Diseases
Therapeutic Uses
Lung Diseases
Antirheumatic Agents
Interferon-gamma, Recombinant

ClinicalTrials.gov processed this record on July 02, 2009