Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043355
Status:
TERMINATED
Last Update Posted:
2007-11-01
First Post:
2002-08-07
Brief Title:
Safety and Efficacy of Inhaled Interferon Gamma-1b in Pulmonary MAC Infection
Sponsor:
InterMune
Organization:
InterMune
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Phase II Study of Safety and Efficacy of Inhaled Interferon Gamma-1b With Antimycobacterials in Previously Treated or Mod-to-Sev Pulmonary Mycobacterium Avium Complex Infection
Status:
TERMINATED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Futility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to test the safety and effectiveness of inhaled Interferon gamma-1b IFN-g 1b when administered for 48 weeks and in combination with oral antibiotics which may be administered for up to 72 weeks for the treatment of a lung infection caused by a bacterium called Mycobacterium avium complex
FDA has not approved Interferon gamma-1b for use in patients with MAC infection of the lungs which is the purpose of this studyInterferon gamma-1b and similar proteins play important roles in establishing and maintaining protective immune responses against a variety of microorganisms
FDA has not approved Interferon gamma-1b for use in patients with MAC infection of the lungs which is the purpose of this studyInterferon gamma-1b and similar proteins play important roles in establishing and maintaining protective immune responses against a variety of microorganisms
Detailed Description:
Laboratory research has shown that a mouse form of interferon gamma is effective in treating mice with infections caused by bacteria similar to MAC as well as MAC infection
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