A Study of the Safety and Efficacy Interferon-Gamma 1b in Patients With Idiopathic Pulmonary Fibrosis (IPF)

NCT ID: NCT00047645

Last Updated: 2007-11-02

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

PHASE3

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-04-30

Study Completion Date

2002-12-31

Brief Summary

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Study GIPF-001 is phase 3 study designed to determine the safety and efficacy of IFN-g 1b administered by subcutaneous injection; compared to placebo in patients with IPF who are unresponsive to steroids. 330 patients have been enrolled and were assigned to either a IFN-g 1b group or a placebo group.

Detailed Description

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Conditions

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Idiopathic Pulmonary Fibrosis

Keywords

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lung IPF

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

200 mcg, SQ, 3x per week

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Male or Female, 20-79 years old
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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Javier Szwarcberg, MD

Role: STUDY_DIRECTOR

InterMune

Locations

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University of Washington Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Wells AU, Jacob J, Sverzellati N, Cross G, Barnett J, De Lauretis A, Antoniou K, Weycker D, Atwood M, Kirchgaessler KU, Cottin V. A formula for predicting emphysema extent in combined idiopathic pulmonary fibrosis and emphysema. Respir Res. 2024 Jan 18;25(1):33. doi: 10.1186/s12931-023-02589-x.

Reference Type DERIVED
PMID: 38238788 (View on PubMed)

Cottin V, Hansell DM, Sverzellati N, Weycker D, Antoniou KM, Atwood M, Oster G, Kirchgaessler KU, Collard HR, Wells AU. Effect of Emphysema Extent on Serial Lung Function in Patients with Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2017 Nov 1;196(9):1162-1171. doi: 10.1164/rccm.201612-2492OC.

Reference Type DERIVED
PMID: 28657784 (View on PubMed)

Other Identifiers

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GIPF-001

Identifier Type: -

Identifier Source: org_study_id