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Safety and Efficacy of Inhaled Interferon Gamma-1b in Pulmonary MAC Infection Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Safety and Efficacy of Inhaled Interferon Gamma-1b in Pulmonary MAC Infection conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Safety and Efficacy of Inhaled Interferon Gamma-1b in Pulmonary MAC Infection Clinical research trials and Safety and Efficacy of Inhaled Interferon Gamma-1b in Pulmonary MAC Infection health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Safety and Efficacy of Inhaled Interferon Gamma-1b in Pulmonary MAC Infection. Safety and Efficacy of Inhaled Interferon Gamma-1b in Pulmonary MAC Infection Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Safety and Efficacy of Inhaled Interferon Gamma-1b in Pulmonary MAC Infection clinical trial. Subjects frequently get the best healthcare possible for their Safety and Efficacy of Inhaled Interferon Gamma-1b in Pulmonary MAC Infection condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.

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Safety and Efficacy of Inhaled Interferon Gamma-1b in Pulmonary MAC Infection



Safety and Efficacy of Inhaled Interferon Gamma-1b in Pulmonary MAC Infection

For Condition: Lung Infection
Status: Terminated
Sponsor(s): InterMune ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 80

Location and Contact Information:


Additional Information:
Study ID Numbers:
  GIMAC-001; 
Study Start Date: December 2000
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043355

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