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

Tracking Information

First Received Date ^ICMJE

August 7, 2002

Last Updated Date

October 29, 2007

Start Date ^ICMJE

April 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

change in sputum neutrophil count [ Time Frame: 4 weeks ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00043342 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

change in predicted FEV1, sputum bacterial density, sputum levels of free neutrophil elastase, DNA and IL-8 [ Time Frame: 4 weeks ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Cystic Fibrosis

Intervention ^ICMJE

Drug: interferon gamma-1b

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00043342

Responsible Party

Study ID Numbers ^ICMJE

GICF-002

Study Sponsor ^ICMJE

InterMune

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Steven Porter, MD

InterMune

Information Provided By

InterMune

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP