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)

Phase 2CompletedNCT00052052

InterMune210 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

210

Conditions

Lung Disease Pulmonary Fibrosis

Interventions

interferon-gamma 1bDRUG

200 mcg, SQ, 3x per week

Eligibility

Sex: ALLMin age: 20 YearsMax age: 79 Years

Medical Language ↔ Plain English

Male or Female Idiopathic Pulmonary Fibrosis 20-79 years Must have participated in the InterMune protocol GIPF-001 study.

Locations (1)

University of Washington Medical Center

Seattle, Washington, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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