Suspended
An Open-Label Study of the Safety of Subcutaneous Recombinant Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis
What is being tested
Data Collection
Who is being recruted
Fibrosis+5
+ Lung Diseases
+ Pathologic Processes
+6 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: November 2003
Summary
Principal SponsorInterMune
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2003
Actual date on which the first participant was enrolled.Open-label therapy will be administered subcutaneously. Patients enrolled will continue to receive Interferon gamma-1b therapy three times per week and will be evaluated at 6-week intervals. Patients not taking Interferon gamma-1b at enrollment will re-initiate therapy with subcutaneous Interferon gamma-1b under a dose-escalation scheme, reaching full dose after 2 weeks.
Official TitleAn Open-Label Study of the Safety of Subcutaneous Recombinant Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis
Principal SponsorInterMune
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
91 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
FibrosisLung DiseasesPathologic ProcessesPulmonary FibrosisRespiratory Tract DiseasesPathological Conditions, Signs and SymptomsLung Diseases, InterstitialIdiopathic Pulmonary Fibrosis
Criteria
3 inclusion criteria required to participate
Enrollment in Protocol GIPF 002 Part B or GIPF-004
Completion of the End of Treatment Visit in Protocol GIPF-002 Part B or the Study Completion Visit in GIPF-004
Able to understand and sign a written informed consent form and comply with the requirements of the study
3 exclusion criteria prevent from participating
pregnancy or lactation
lack of adherence to either GIPF-002 or GIPF-004 study protocols and treatment regimens
if Principal Investigator deems patient is unsuitable for study
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
SuspendedOne Study Center