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Safety and Efficacy of Inhaled Interferon Gamma-1b in Pulmonary MAC Infection
This study has been terminated.
( Futility )
Study NCT00043355   Information provided by InterMune
First Received: August 7, 2002   Last Updated: October 30, 2007   History of Changes

August 7, 2002
October 30, 2007
December 2000
 
sustained culture conversion [ Time Frame: 52 weeks ]
Same as current
Complete list of historical versions of study NCT00043355 on ClinicalTrials.gov Archive Site
 
 
 
Safety and Efficacy of Inhaled Interferon Gamma-1b in Pulmonary MAC Infection
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

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 study.Interferon gamma-1b and similar proteins play important roles in establishing and maintaining protective immune responses against a variety of microorganisms.

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.

Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Lung Infection
Drug: interferon gamma-1b
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
100
February 2003
 

Male and female patients, 18 years of age or older, with bacteriologically and radiographically confirmed pulmonary MAC infection who have been treated for their infection for at least 6 months within the previous 2 years, as well as patients with moderate or severe pulmonary disease due to MAC, not previously treated for this infection. Patients with recurrent pulmonary MAC infection after previous successful treatment for pulmonary MAC disease are also eligible.

In addition, various laboratory testing must confirm conditions. Patients cannot be positive for HIV or have an extra-pulmonary (in general, outside of the lungs) infection of MAC. Other preconditions related to health or other conditions exist as factors for inclusion or exclusion from this study.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00043355
 
GIMAC-001
InterMune
 
Study Director: Steven Porter, MD InterMune
InterMune
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP