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NCT00052052 Clinical Trial

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)

Pulmonary Fibrosis Clinical Trial

Official title:
An Open-Label Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00052052
Other study ID # GIPF-004
Secondary ID
Status Completed
Phase Phase 2
First received January 21, 2003
Last updated November 2, 2007
Start date September 2002
Est. completion date September 2004

Study information
Verified date November 2007
Source InterMune
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 210
Est. completion date September 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 79 Years
Eligibility Male or Female

Idiopathic Pulmonary Fibrosis

20-79 years

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• interferon-gamma 1b
200 mcg, SQ, 3x per week

Locations
Country Name City State
United States University of Washington Medical Center Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
InterMune

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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