A Randomized, Double-Blind, Three-Arm, Phase 3b Study Comparing the Safety and Efficacy of Interferon Gamma-1b With Azathioprine, and Azathioprine Alone in Patients With IPF Receiving Prednisone

This study has been terminated.
(Study design changes were needed based on GIPF-001 results)
Sponsor:
Information provided by:
InterMune
ClinicalTrials.gov Identifier:
NCT00052039
First received: January 21, 2003
Last updated: November 2, 2007
Last verified: November 2007
  Purpose

Study GIPF-003 is a Phase 3b study designed to define better therapeutic use of IFN-gamma 1b in patients wtih IPF. The study will be conducted primarily in Europe and will enroll 210 patients.


Condition Intervention Phase
Lung Disease
Pulmonary Fibrosis
Drug: interferon-gamma 1b
Drug: azathioprine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Three-Arm, Phase IIIb Study Comparing the Safety and Efficacy of Interferon Gamma-1b Alone, IFN-Gamma 1b With Azathioprine, and Azathioprine Alone in Patients With Idiopathic Pulmonary Fibrosis Receiving Prednisone

Resource links provided by NLM:


Further study details as provided by InterMune:

Primary Outcome Measures:
  • This study was terminated prior to enrollment. [ Time Frame: This study was terminated prior to enrollment. ]

Enrollment: 0
Study Start Date: April 2002
Study Completion Date: June 2002
Intervention Details:
    Drug: interferon-gamma 1b
    This study was terminated prior to enrollment.
    Drug: azathioprine
    This study was terminated prior to enrollment.
  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00052039

Locations
Italy
Ospedale S. Luigi Gonzaga - Regione
Torino, Orbassano, Italy, 10043
Sponsors and Collaborators
InterMune
Investigators
Study Director: Steven Porter, MD InterMune
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00052039     History of Changes
Other Study ID Numbers: GIPF-003
Study First Received: January 21, 2003
Last Updated: November 2, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by InterMune:
idiopathic pulmonary fibrosis

Additional relevant MeSH terms:
Fibrosis
Lung Diseases
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Azathioprine
Interferons
Prednisone
Interferon-gamma
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antiviral Agents
Anti-Infective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 22, 2014