A Phase 3 interventional study of Interferon gamma-1b in Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis and Lung Disease, sponsored by InterMune. Terminated at 1 site in United States. Per ClinicalTrials.gov, last updated 2007-11-06.
Sponsored by InterMune (part of Hoffmann-La Roche) · Phase 3, Interventional, and Treatment
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.
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.
576 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 123 are open to participants now.
This study's enrollment of 91 is above the median of 55 across 389 interventional studies indexed under Idiopathic Pulmonary Fibrosis.
Browse Idiopathic Pulmonary Fibrosis studies →InterMune is the lead sponsor of 15 studies on the registry; none are open to participants now.
First submitted before InterMune became part of Hoffmann-La Roche.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
200 mcg, SQ, 3x per week
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
This study is terminated, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Interferon gamma-1b
Idiopathic Pulmonary Fibrosis →