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

This study has been completed.

Sponsored by: InterMune
Information provided by: InterMune
ClinicalTrials.gov Identifier: NCT00047645
  Purpose

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.


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

MedlinePlus related topics:   Pulmonary Fibrosis   

Drug Information available for:   Interferon alfa-2b    Interferons    Interferon gamma-1b   

U.S. FDA Resources

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

Further study details as provided by InterMune:

Primary Outcome Measures:
  • Progression-free survival time [ Time Frame: 2 years ]

Enrollment:   330
Study Start Date:   April 2000
Study Completion Date:   December 2002

Intervention Details:
    Drug: Interferon-gamma 1b
    200 mcg, SQ, 3x per week
  Eligibility
Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Male or Female, 20-79 years old

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00047645

Locations
United States, Washington
University of Washington Medical Center    
      Seattle, Washington, United States, 98195

Sponsors and Collaborators
InterMune

Investigators
Study Director:     Javier Szwarcberg, MD     InterMune    
  More Information


Study ID Numbers:   GIPF-001
First Received:   October 9, 2002
Last Updated:   November 1, 2007
ClinicalTrials.gov Identifier:   NCT00047645
Health Authority:   United States: Food and Drug Administration

Keywords provided by InterMune:
lung  
IPF  

Study placed in the following topic categories:
Interferon-alpha
Lung Diseases, Interstitial
Interferon Type II
Fibrosis
Hamman-Rich syndrome
Interferons
Pulmonary Fibrosis
Respiratory Tract Diseases
Lung Diseases
Fibrosing alveolitis
Interferon Alfa-2a
Interferon Alfa-2b
Interferon-gamma, Recombinant

Additional relevant MeSH terms:
Anti-Infective Agents
Pathologic Processes
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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