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 on January 21, 2003. Last Updated on November 2, 2007 History of Changes

Sponsor:	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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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:

Genetics Home Reference related topics: idiopathic pulmonary fibrosis

MedlinePlus related topics: Pulmonary Fibrosis

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

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

Keywords provided by InterMune:

idiopathic pulmonary fibrosis

Additional relevant MeSH terms:

Fibrosis
Lung Diseases
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Azathioprine
Interferon-gamma, Recombinant
Interferons
Prednisone
Interferon-gamma
Antimetabolites
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antiviral Agents
Anti-Infective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 12, 2012