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

InterMune

Status and phase

Completed

Phase 2

Phase 1

Conditions

Cystic Fibrosis

Treatments

Drug: interferon gamma-1b

Study type

Interventional

Funder types

Industry

Identifiers

NCT00043342

GICF-002

Details and patient eligibility

About

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.

Enrollment

51 patients

Sex

All

Ages

6+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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