Safety and Efficacy of Inhaled Interferon Gamma-1b in Pulmonary MAC Infection
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|ClinicalTrials.gov Identifier: NCT00043355|
Recruitment Status : Terminated (Futility)
First Posted : August 12, 2002
Last Update Posted : November 1, 2007
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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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Infection||Drug: interferon gamma-1b||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||December 2000|
|Actual Study Completion Date :||February 2003|
- Drug: interferon gamma-1b
500 mcg, oral, three times weekly
- sustained culture conversion [ Time Frame: 52 weeks ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00043355
|Study Director:||Steven Porter, MD||InterMune|
|Other Study ID Numbers:||
|First Posted:||August 12, 2002 Key Record Dates|
|Last Update Posted:||November 1, 2007|
|Last Verified:||October 2007|
mycobacterium avium complex infection