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

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

This study has been terminated.
Information provided by InterMune

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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 ]

Secondary Outcome Measure ^†

Condition ^†

Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Lung Disease

Intervention ^†

Drug: Interferon gamma-1b

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Terminated

Enrollment ^†

Start Date ^†

November 2003

Completion Date

April 2007

Eligibility 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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00076635

Organization ID

GIPF-006

Secondary IDs ^††

Study Sponsor ^†

InterMune

Collaborators ^††

Investigators ^†

Investigator:

InterMune, Inc. 888-486-6411

Medical Information

Information Provided By

InterMune

Verification Date

November 2007

First Received Date ^†

January 28, 2004

Last Updated Date

November 2, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.