NCT00047645

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
330

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2000

Typical duration for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2002

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
Last Updated

November 2, 2007

Status Verified

November 1, 2007

First QC Date

October 9, 2002

Last Update Submit

November 1, 2007

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

lungIPF

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival time

    2 years

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, 20-79 years old

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

Related Publications (2)

  • 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.

    PMID: 38238788DERIVED

  • 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.

    PMID: 28657784DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Interferon-gamma

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

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 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 9, 2002

First Posted

October 11, 2002

Study Start

April 1, 2000

Study Completion

December 1, 2002

Last Updated

November 2, 2007

Record last verified: 2007-11

Locations

US(1)