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CompletedNCT00052052Updated Nov 6, 2007

An Open-Label Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon-Gamma 1b (IFN-Gamma 1b) in Patients With Idiopathic Pulmonary Fibrosis (IPF)

A Phase 2 interventional study of interferon-gamma 1b in Lung Disease and Pulmonary Fibrosis, sponsored by InterMune. Completed at 1 site in United States. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2007-11-06.

Primary conditionIdiopathic Pulmonary FibrosisRegistry: Lung DiseasesReclassifiedWhy we changed it
Registry
Lung Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Idiopathic Pulmonary Fibrosis
Why
  1. The study's title name Idiopathic Pulmonary Fibrosis, a narrower term within Lung Diseases.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by InterMune (part of Hoffmann-La Roche) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
20 Years to 79 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Lung Disease
  • Pulmonary Fibrosis

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Keywords

  • idiopathic pulmonary fibrosis
  • IPF
03

In context

Idiopathic Pulmonary Fibrosis Reclassified

576 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 123 are open to participants now.

This study's enrollment of 210 is above the median of 55 across 389 interventional studies indexed under Idiopathic Pulmonary Fibrosis.

Browse Idiopathic Pulmonary Fibrosis studies →

Lead sponsor

InterMune is the lead sponsor of 15 studies on the registry; none are open to participants now.

First submitted before InterMune became part of Hoffmann-La Roche.

Browse InterMune studies →All Hoffmann-La Roche studies →

Compared within Idiopathic Pulmonary Fibrosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lung Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
20 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Male or Female

Idiopathic Pulmonary Fibrosis

20-79 years

Must have participated in the InterMune protocol GIPF-001 study.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
210 participants (actual)

Interventions

06

What researchers measure

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

    Time frame: 48 weeks

07

Study locations

1 site
  • University of Washington Medical Center
    Seattle, Washington 98195, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2002 and a completion of Sep 2004. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 21, 2003
First posted
Jan 23, 2003
Start
Sep 2002
CompletionActual
Sep 2004
Last update
Nov 6, 2007
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 6, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00052052
Lead sponsor
InterMune
First posted
Jan 23, 2003
Start date
Sep 2002
Completion
Sep 2004
Last update
Nov 6, 2007

Study contacts

Javier Szwarcberg, MD
study director · InterMune
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Interferon gamma-1b

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