Safety and Efficacy of Inhaled Interferon Gamma-1b in Pulmonary MAC Infection
Information source: InterMune
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lung Infection
Intervention: interferon gamma-1b (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: InterMune Official(s) and/or principal investigator(s):
Steven Porter, MD, Study Director, Affiliation: InterMune
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: sustained culture conversion
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: December 2000
Ending date: February 2003
Last updated: October 30, 2007
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