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

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

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

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

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:

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

No publications provided

Study ID Numbers:	GIPF-006
Study First Received:	January 28, 2004
Last Updated:	November 2, 2007
ClinicalTrials.gov Identifier:	NCT00076635 History of Changes
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:

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 August 30, 2009