Study of Interferon Gamma-1b by Injection for the Treatment of Patients With Cystic Fibrosis

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interferon gamma-1b

Drug

100 or 200 mcg, SQ, 3x per week

Primary outcomes

change in sputum neutrophil count

Time frame: 4 weeks

Secondary outcomes

change in predicted FEV1, sputum bacterial density, sputum levels of free neutrophil elastase, DNA and IL-8

Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

InterMune

Industry

Registry information

Official study title

A Phase I/II Study of Interferon Gamma-1b by Subcutaneous Injection for the Treatment of Patients With Cystic Fibrosis

Important dates

Study start: 2002
Study completion: 2003
First posted: Aug 12, 2002
Registry last updated: Nov 1, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed