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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2003-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cystic Fibrosis

Keywords

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cystic fibrosis pulmonary impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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interferon gamma-1b

100 or 200 mcg, SQ, 3x per week

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Steven Porter, MD

Role: STUDY_DIRECTOR

InterMune

Countries

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United States

Other Identifiers

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GICF-002

Identifier Type: -

Identifier Source: org_study_id