Back to resultsSafety and Efficacy of Inhaled Interferon Gamma-1b in Pulmonary MAC Infection
Primary Purpose
Lung Infection
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
interferon gamma-1b
Sponsored by
About this trial
This is an interventional treatment trial for Lung Infection focused on measuring pulmonary, mycobacterium avium complex infection, MAC, nontuberculous, mycobacteria, lung
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
sustained culture conversion
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00043355
Brief Title
Safety and Efficacy of Inhaled Interferon Gamma-1b in Pulmonary MAC Infection
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 Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Terminated
Why Stopped
Futility
Study Start Date
December 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
InterMune
4. Oversight
5. Study Description
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 study.Interferon 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Infection
Keywords
pulmonary, mycobacterium avium complex infection, MAC, nontuberculous, mycobacteria, lung
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
interferon gamma-1b
Intervention Description
500 mcg, oral, three times weekly
Primary Outcome Measure Information:
Title
sustained culture conversion
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Porter, MD
Organizational Affiliation
InterMune
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Inhaled Interferon Gamma-1b in Pulmonary MAC Infection
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