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

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ClinicalTrials.gov Identifier: NCT00043342
Recruitment Status : Completed
First Posted : August 12, 2002
Last Update Posted : November 1, 2007
Sponsor:
Information provided by:
InterMune

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: interferon gamma-1b Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Interferon Gamma-1b by Subcutaneous Injection for the Treatment of Patients With Cystic Fibrosis
Study Start Date : April 2002
Actual Study Completion Date : March 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources


Intervention Details:
    Drug: interferon gamma-1b
    100 or 200 mcg, SQ, 3x per week


Primary Outcome Measures :
  1. change in sputum neutrophil count [ Time Frame: 4 weeks ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00043342


Sponsors and Collaborators
InterMune
Investigators
Study Director: Steven Porter, MD InterMune

ClinicalTrials.gov Identifier: NCT00043342     History of Changes
Other Study ID Numbers: GICF-002
First Posted: August 12, 2002    Key Record Dates
Last Update Posted: November 1, 2007
Last Verified: October 2007

Keywords provided by InterMune:
cystic fibrosis
pulmonary impairment

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Interferons
Interferon-gamma
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents