NCT00043342

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2002

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2002

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2002

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
Last Updated

November 1, 2007

Status Verified

October 1, 2007

First QC Date

August 7, 2002

Last Update Submit

October 29, 2007

Conditions

Cystic Fibrosis

Keywords

cystic fibrosispulmonary impairment

Outcome Measures

Primary Outcomes (1)

  • change in sputum neutrophil count

    4 weeks

Secondary Outcomes (1)

  • change in predicted FEV1, sputum bacterial density, sputum levels of free neutrophil elastase, DNA and IL-8

    4 weeks

Interventions

interferon gamma-1bDRUG

100 or 200 mcg, SQ, 3x per week

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

interferon gamma-1b

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Steven Porter, MD

    InterMune

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 7, 2002

First Posted

August 12, 2002

Study Start

April 1, 2002

Study Completion

March 1, 2003

Last Updated

November 1, 2007

Record last verified: 2007-10