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

Tracking Information

First Received Date ^ICMJE

January 28, 2004

Last Updated Date

November 2, 2007

Start Date ^ICMJE

November 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

All adverse events up to the end of study
Survival status at end of study
Serum antibodies to Interferon gamma-1b after the last injection.

Change History

Complete list of historical versions of study NCT00076635 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

No secondary outcomes

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Condition ^ICMJE

Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Lung Disease

Intervention ^ICMJE

Drug: Interferon gamma-1b

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

April 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00076635

Responsible Party

Study ID Numbers ^ICMJE

GIPF-006

Study Sponsor ^ICMJE

InterMune

Collaborators ^ICMJE

Investigators ^ICMJE

Investigator:

InterMune, Inc. 888-486-6411

Medical Information

Information Provided By

InterMune

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP