Study of Interferon Gamma-1b by Injection for the Treatment of Patients With Cystic Fibrosis
Information source: InterMune
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystic Fibrosis
Intervention: interferon gamma-1b (Drug)
Phase: Phase 1/Phase 2
Status: Completed
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 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.
Clinical Details
Official title: A Phase I/II Study of Interferon Gamma-1b by Subcutaneous Injection for the Treatment of Patients With Cystic Fibrosis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: change in sputum neutrophil count
Secondary outcome: change in predicted FEV1, sputum bacterial density, sputum levels of free neutrophil elastase, DNA and IL-8
Eligibility
Minimum age: 6 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: April 2002
Last updated: October 29, 2007
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