Expired Study
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Brisbane, California 94005


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.


Study summary:

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.


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


NCT ID:

NCT00076635


Primary Contact:

InterMune, Inc. 888-486-6411
Medical Information


Backup Contact:

N/A


Location Contact:

Brisbane, California 94005
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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