An Open-Label Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon-Gamma 1b (IFN-Gamma 1b) in Patients With Idiopathic Pulmonary Fibrosis (IPF)

This study has been completed.

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

Sponsored by:	InterMune
Information provided by:	InterMune
ClinicalTrials.gov Identifier:	NCT00052052

Purpose

Study GIPF-004 is an open-label, multicenter study that will enroll approximately 250 patients who complete Protocol GIPF-001. The purpose of this study is to assess the safety and efficacy of continued IFN-gamma 1b therapy in this well-defined cohort of patients for up to 48 weeks.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis.

Resource links provided by NLM:

MedlinePlus related topics: Pulmonary Fibrosis

Drug Information available for: Interferon gamma-1b Interferons

U.S. FDA Resources

Further study details as provided by InterMune:

Primary Outcome Measures:

FVC, dyspnea, DLCO, A-a gradient at rest,SGRQ,survival time, use of supplemental oxygen, QOL SF-36, TLC, time to lung transplantation or death due to IPF [ Time Frame: 48 weeks ]

Enrollment:	210
Study Start Date:	September 2002
Study Completion Date:	September 2004

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

Idiopathic Pulmonary Fibrosis

20-79 years

Must have participated in the InterMune protocol GIPF-001 study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00052052

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

No publications provided

Study ID Numbers:	GIPF-004
Study First Received:	January 21, 2003
Last Updated:	November 2, 2007
ClinicalTrials.gov Identifier:	NCT00052052 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by InterMune:

idiopathic pulmonary fibrosis
IPF

Study placed in the following topic categories:

Anti-Infective Agents
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 September 11, 2009