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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00047658
First Posted: October 11, 2002
Last Update Posted: November 6, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
InterMune
  Purpose
Study GIPF-002 is a phase 2 study designed to characterize the biologic and clinical effects of IFN-g 1b. The objective of the Study is to characterize the biologic and clinical effects of IFN-g 1b administered to patients with idiopathic pulmonary fibrosis (IPF). The Study will be conducted at multiple sites and enroll 30 patients with IPF who have failed treatment with corticosteroids.

Condition Intervention Phase
Idiopathic Pulmonary Fibrosis Drug: Interferon-gamma 1b Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Biology, and Clinical Effects of Interferon Gamma-1b Administered Subcutaneously to Patients With IPF Followed by an Open-Label Extension

Resource links provided by NLM:


Further study details as provided by InterMune:

Primary Outcome Measures:
  • change in percent predicted FVC, resting arterial blood gas assessment of alveolar-arterial oxygen gradient, percent predicted DLCO, dyspnea scale, baseline dyspnea index/transition dyspnea index [ Time Frame: 23 weeks ]

Enrollment: 32
Study Start Date: November 2001
Study Completion Date: May 2003
Intervention Details:
    Drug: Interferon-gamma 1b
    200 mcg, SQ, 3x per week
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Male or Female 20-79 years old
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00047658


Locations
United States, California
UCLA, Dept. of Medicine
Los Angeles, California, United States, 90095
Sponsors and Collaborators
InterMune
Investigators
Study Director: Williamson Bradford, MD InterMune
  More Information

ClinicalTrials.gov Identifier: NCT00047658     History of Changes
Other Study ID Numbers: GIPF-002
First Submitted: October 9, 2002
First Posted: October 11, 2002
Last Update Posted: November 6, 2007
Last Verified: November 2007

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Interferons
Interferon-gamma
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents