Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076635
Status:
TERMINATED
Last Update Posted:
2007-11-06
First Post:
2004-01-28
Brief Title:
An Open-Label Study of the Safety of Interferon Gamma-1b in Patients With IPF
Sponsor:
InterMune
Organization:
InterMune
Study Overview
Official Title:
An Open-Label Study of the Safety of Subcutaneous Recombinant Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis
Status:
TERMINATED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
program discontinued based on GIPF-007 results
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None