Back to resultsStudy of Interferon Gamma-1b by Injection for the Treatment of Patients With Cystic Fibrosis
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
interferon gamma-1b
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring cystic fibrosis, pulmonary impairment
Eligibility Criteria
At least 6 years of age Diagnosis of cystic fibrosis (against certain criteria) Able to perform pulmonary (lung) function tests and participate in induced sputum procedures Pulmonary function values must meet certain minimal requirements Must have acceptable laboratory test results Cannot be on certain medications during and immediately prior to study Cannot have a history of unstable or deteriorating cardiac or neurologic disease
Sites / Locations
Outcomes
Primary Outcome Measures
change in sputum neutrophil count
Secondary Outcome Measures
change in predicted FEV1, sputum bacterial density, sputum levels of free neutrophil elastase, DNA and IL-8
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00043342
Brief Title
Study of Interferon Gamma-1b by Injection for the Treatment of Patients With Cystic Fibrosis
Official Title
A Phase I/II Study of Interferon Gamma-1b by Subcutaneous Injection for the Treatment of Patients With Cystic Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 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 evaluate the safety, tolerability, and efficacy of Interferon gamma-1b (IFN-gamma 1b) when administered by subcutaneous injection over a period of 4 weeks to patients with mild-to-moderate cystic fibrosis. Additionally, preliminary assessments on the effects of IFN-gamma 1b on lung function and other indicators of health will be made.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
cystic fibrosis, pulmonary impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
interferon gamma-1b
Intervention Description
100 or 200 mcg, SQ, 3x per week
Primary Outcome Measure Information:
Title
change in sputum neutrophil count
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
change in predicted FEV1, sputum bacterial density, sputum levels of free neutrophil elastase, DNA and IL-8
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
At least 6 years of age
Diagnosis of cystic fibrosis (against certain criteria)
Able to perform pulmonary (lung) function tests and participate in induced sputum procedures
Pulmonary function values must meet certain minimal requirements
Must have acceptable laboratory test results
Cannot be on certain medications during and immediately prior to study
Cannot have a history of unstable or deteriorating cardiac or neurologic disease
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
Study of Interferon Gamma-1b by Injection for the Treatment of Patients With Cystic Fibrosis
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