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

Sponsor:	InterMune
Information provided by:	InterMune
ClinicalTrials.gov Identifier:	NCT00043342

Purpose

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.

Condition	Intervention	Phase
Cystic Fibrosis	Drug: interferon gamma-1b	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I/II Study of Interferon Gamma-1b by Subcutaneous Injection for the Treatment of Patients With Cystic Fibrosis

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: Interferon gamma-1b Interferons

U.S. FDA Resources

Further study details as provided by InterMune:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	51
Study Start Date:	April 2002
Study Completion Date:	March 2003

Intervention Details:

100 or 200 mcg, SQ, 3x per week

Eligibility

Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043342

Sponsors and Collaborators

InterMune

Investigators

Study Director:

Steven Porter, MD

InterMune

More Information

No publications provided

Study ID Numbers:	GICF-002
Study First Received:	August 7, 2002
Last Updated:	October 29, 2007
ClinicalTrials.gov Identifier:	NCT00043342 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by InterMune:

cystic fibrosis
pulmonary impairment

Additional relevant MeSH terms:

Anti-Infective Agents
Interferon Type II
Antineoplastic Agents
Fibrosis
Interferons
Antiviral Agents
Pharmacologic Actions
Digestive System Diseases
Pathologic Processes

Cystic Fibrosis
Respiratory Tract Diseases
Genetic Diseases, Inborn
Therapeutic Uses
Lung Diseases
Pancreatic Diseases
Infant, Newborn, Diseases
Interferon-gamma, Recombinant

ClinicalTrials.gov processed this record on February 08, 2010