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

• ClinicalTrials.gov Identifier: NCT00043355
• Recruitment Status: Terminated
• First Posted: August 12, 2002
• Last Update Posted: November 1, 2007
• Sponsor: InterMune
• Information provided by: InterMune

Tracking Information

• First Submitted Date: August 7, 2002
• First Posted Date: August 12, 2002
• Last Update Posted Date: November 1, 2007
• Study Start Date: December 2000
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: October 30, 2007): sustained culture conversion [ Time Frame: 52 weeks ]
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Lung Infection

Intervention

Drug: interferon gamma-1b

500 mcg, oral, three times weekly

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: October 30, 2007): 100
• Original Enrollment (submitted: June 23, 2005): 80
• Actual Study Completion Date: February 2003
• Primary Completion Date: Not Provided

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00043355
• Other Study ID Numbers: GIMAC-001
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: InterMune
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Steven Porter, MD; InterMune

• PRS Account: InterMune
• Verification Date: October 2007