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

October 29, 2007 updated by: InterMune

A Phase I/II Study of Interferon Gamma-1b by Subcutaneous 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in sputum neutrophil count
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InterMune

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Study Completion (Actual)

March 1, 2003

Study Registration Dates

First Submitted

August 7, 2002

First Submitted That Met QC Criteria

August 9, 2002

First Posted (Estimate)

August 12, 2002

Study Record Updates

Last Update Posted (Estimate)

November 1, 2007

Last Update Submitted That Met QC Criteria

October 29, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GICF-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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