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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

Page last updated: August 20, 2015

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