A Randomized, Double-Blind, Three-Arm, Phase 3b Study Comparing the Safety and Efficacy of Interferon Gamma-1b With Azathioprine, and Azathioprine Alone in Patients With IPF Receiving Prednisone

NCT ID: NCT00052039

Last Updated: 2007-11-06

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

TERMINATED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2002-06-30

Brief Summary

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Study GIPF-003 is a Phase 3b study designed to define better therapeutic use of IFN-gamma 1b in patients wtih IPF. The study will be conducted primarily in Europe and will enroll 210 patients.

Detailed Description

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Conditions

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Lung Disease Pulmonary Fibrosis

Keywords

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idiopathic pulmonary fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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interferon-gamma 1b

This study was terminated prior to enrollment.

Intervention Type DRUG

azathioprine

This study was terminated prior to enrollment.

Intervention Type DRUG

Eligibility Criteria

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Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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InterMune

INDUSTRY

Sponsor Role lead

Principal Investigators

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Steven Porter, MD

Role: STUDY_DIRECTOR

InterMune

Locations

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Ospedale S. Luigi Gonzaga - Regione

Torino, Orbassano, Italy

Site Status

Countries

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Italy

Other Identifiers

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GIPF-003

Identifier Type: -

Identifier Source: org_study_id