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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014