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

This study has been completed.
Sponsor:
Information provided by:
InterMune
ClinicalTrials.gov Identifier:
NCT00043342
First received: August 7, 2002
Last updated: October 29, 2007
Last verified: October 2007
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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:
    Drug: interferon gamma-1b
    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

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

Keywords provided by InterMune:
cystic fibrosis
pulmonary impairment

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

ClinicalTrials.gov processed this record on April 14, 2014