MedTrace Logo

The INSPIRE Trial: A Study of Interferon Gamma-1b for Idiopathic Pulmonary Fibrosis (IPF)

NCT00075998 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 826

Last updated 2009-07-02

No results posted yet for this study

Summary

* Purpose: A phase 3, randomized, double-blind, placebo-controlled trial to determine the efficacy and safety of 200 µg of recombinant Interferon gamma-1b administered by subcutaneous (SC) injection, compared with placebo, in patients with IPF
* Enrollment: Approximately 800 patients will be enrolled from approximately 80 centers in North America and Europe
* Randomization: 2:1 active-to-placebo ratio
* Duration: at least 2 years active drug or placebo (rescue therapy will be permitted for patients who meet predefined criteria)

Conditions

Interventions

DRUG

Interferon gamma-1b ("Actimmune")

200 mcg, SQ, 3x per week

Sponsors & Collaborators

  • InterMune

    lead INDUSTRY

Principal Investigators

  • InterMune, Inc. · Medical Information

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Completion
2007-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00075998 on ClinicalTrials.gov