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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00043355
Recruitment Status : Terminated (Futility)
First Posted : August 12, 2002
Last Update Posted : November 1, 2007
Sponsor:
Information provided by:
InterMune

Tracking Information
First Submitted Date  ICMJE August 7, 2002
First Posted Date  ICMJE August 12, 2002
Last Update Posted Date November 1, 2007
Study Start Date  ICMJE December 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2007)
sustained culture conversion [ Time Frame: 52 weeks ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00043355 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Inhaled Interferon Gamma-1b in Pulmonary MAC Infection
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lung Infection
Intervention  ICMJE Drug: interferon gamma-1b
500 mcg, oral, three times weekly
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 30, 2007)
100
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
80
Actual Study Completion Date  ICMJE February 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00043355
Other Study ID Numbers  ICMJE GIMAC-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE InterMune
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Steven Porter, MD InterMune
PRS Account InterMune
Verification Date October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP