NCT00052039

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Timeline
Completed

Started Apr 2002

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

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
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2002

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 22, 2003

Completed
Last Updated

November 6, 2007

Status Verified

November 1, 2007

First QC Date

January 21, 2003

Last Update Submit

November 2, 2007

Conditions

Lung DiseasePulmonary Fibrosis

Keywords

idiopathic pulmonary fibrosis

Outcome Measures

Primary Outcomes (1)

  • This study was terminated prior to enrollment.

    This study was terminated prior to enrollment.

Interventions

interferon-gamma 1bDRUG

This study was terminated prior to enrollment.

azathioprineDRUG

This study was terminated prior to enrollment.

Sponsors & Collaborators

Study Sites (1)

Ospedale S. Luigi Gonzaga - Regione

Torino, Orbassano, 10043, Italy

Location

MeSH Terms

Conditions

Lung DiseasesPulmonary FibrosisIdiopathic Pulmonary Fibrosis

Interventions

Interferon-gammaAzathioprine

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesLung Diseases, InterstitialFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

InterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsMacrophage-Activating FactorsLymphokinesProteinsBiological FactorsThionucleosidesSulfur CompoundsOrganic ChemicalsMercaptopurinePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Steven Porter, MD

    InterMune

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 21, 2003

First Posted

January 22, 2003

Study Start

April 1, 2002

Study Completion

June 1, 2002

Last Updated

November 6, 2007

Record last verified: 2007-11

Locations

IT(1)