NCT00052052

Brief Summary

Study GIPF-004 is an open-label, multicenter study that will enroll approximately 250 patients who complete Protocol GIPF-001. The purpose of this study is to assess the safety and efficacy of continued IFN-gamma 1b therapy in this well-defined cohort of patients for up to 48 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2002

Geographic Reach
1 country

1 active site

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

September 1, 2002

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 23, 2003

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

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 fibrosisIPF

Outcome Measures

Primary Outcomes (1)

  • FVC, dyspnea, DLCO, A-a gradient at rest,SGRQ,survival time, use of supplemental oxygen, QOL SF-36, TLC, time to lung transplantation or death due to IPF

    48 weeks

Interventions

interferon-gamma 1bDRUG

200 mcg, SQ, 3x per week

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Male or Female Idiopathic Pulmonary Fibrosis 20-79 years Must have participated in the InterMune protocol GIPF-001 study.

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

Sponsors & Collaborators

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Lung DiseasesPulmonary FibrosisIdiopathic Pulmonary Fibrosis

Interventions

Interferon-gamma

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 Factors

Study Officials

  • Javier Szwarcberg, MD

    InterMune

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 21, 2003

First Posted

January 23, 2003

Study Start

September 1, 2002

Study Completion

September 1, 2004

Last Updated

November 6, 2007

Record last verified: 2007-11

Locations

US(1)