A Study of the Safety and Efficacy Interferon-Gamma 1b in Patients With Idiopathic Pulmonary Fibrosis (IPF) - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

October 9, 2002

Last Updated Date

November 1, 2007

Start Date ^†

April 2000

Current Primary Outcome Measures ^†

Progression-free survival time [ Time Frame: 2 years ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00047645 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

A Study of the Safety and Efficacy Interferon-Gamma 1b in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Official Title ^†

A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon-Gamma 1b in Patients With Idiopathic Pulmonary Fibrosis

Brief Summary

Study GIPF-001 is phase 3 study designed to determine the safety and efficacy of IFN-g 1b administered by subcutaneous injection; compared to placebo in patients with IPF who are unresponsive to steroids. 330 patients have been enrolled and were assigned to either a IFN-g 1b group or a placebo group.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Idiopathic Pulmonary Fibrosis

Intervention ^†

Drug: Interferon-gamma 1b

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

330

Completion Date

December 2002

Primary Completion Date

Eligibility Criteria ^†

Male or Female, 20-79 years old

Gender

Both

Ages

20 Years to 79 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00047645

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

InterMune

Collaborators ^††

Investigators ^†

Study Director:

Javier Szwarcberg, MD

InterMune

Information Provided By

InterMune

Verification Date

November 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.