An Open-Label Study of the Safety of Interferon Gamma-1b in Patients With IPF - Full Text View

Purpose

Open-label therapy will be administered to up to 220 patients, following completion of either InterMune Protocol GIPF-002 Part B or Protocol GIPF-004, to assess the long-term safety of subcutaneous Interferon gamma-1b. The study duration will be 5 years.

Condition	Intervention	Phase
Idiopathic Pulmonary Fibrosis Pulmonary Fibrosis Lung Disease	Drug: Interferon gamma-1b	Phase III

MedlinePlus related topics:

Pulmonary Fibrosis

ChemIDplus related topics:

Interferon alfa-2b Interferons Interferon gamma-1b

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Official Title:	An Open-Label Study of the Safety of Subcutaneous Recombinant Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis

Further study details as provided by InterMune:

Primary Outcome Measures:

All adverse events up to the end of study [ Time Frame: 3.5 years ]
Survival status at end of study [ Time Frame: 3.5 years ]
Serum antibodies to Interferon gamma-1b after the last injection. [ Time Frame: 3.5 years ]

Enrollment:	91
Study Start Date:	November 2003
Study Completion Date:	April 2007

Intervention Details:

200 mcg, SQ, 3x per week

Detailed Description:

Open-label therapy will be administered subcutaneously. Patients enrolled will continue to receive Interferon gamma-1b therapy three times per week and will be evaluated at 6-week intervals. Patients not taking Interferon gamma-1b at enrollment will re-initiate therapy with subcutaneous Interferon gamma-1b under a dose-escalation scheme, reaching full dose after 2 weeks.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Enrollment in Protocol GIPF 002 Part B or GIPF-004
Completion of the End of Treatment Visit in Protocol GIPF-002 Part B or the Study Completion Visit in GIPF-004
Able to understand and sign a written informed consent form and comply with the requirements of the study

Exclusion criteria:

pregnancy or lactation
lack of adherence to either GIPF-002 or GIPF-004 study protocols and treatment regimens
if Principal Investigator deems patient is unsuitable for study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076635

Locations


United States, California
	Intermune Inc
	Brisbane, California, United States, 94005

Sponsors and Collaborators

InterMune

Investigators


Investigator:	InterMune, Inc. 888-486-6411	Medical Information

More Information

Study ID Numbers:	GIPF-006
First Received:	January 28, 2004
Last Updated:	November 2, 2007
ClinicalTrials.gov Identifier:	NCT00076635
Health Authority:	United States: Food and Drug Administration

Keywords provided by InterMune:

Idiopathic

Pulmonary

Fibrosis

IPF

Lung

Actimmune

Interferon

Gamma

InterMune

Study placed in the following topic categories:

Interferon-alpha

Lung Diseases, Interstitial

Interferon Type II

Fibrosis

Hamman-Rich syndrome

Interferons

Pulmonary Fibrosis

Respiratory Tract Diseases

Lung Diseases

Fibrosing alveolitis

Interferon Alfa-2a

Interferon Alfa-2b

Interferon-gamma, Recombinant

Additional relevant MeSH terms:

Anti-Infective Agents

Pathologic Processes

Antineoplastic Agents

Growth Substances

Therapeutic Uses

Physiological Effects of Drugs

Growth Inhibitors

Angiogenesis Modulating Agents

Angiogenesis Inhibitors

Antiviral Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 04, 2008

Sponsored by:	InterMune
Information provided by:	InterMune
ClinicalTrials.gov Identifier:	NCT00076635