An Open-Label Study of the Safety of Interferon Gamma-1b in Patients With IPF

This study has been terminated.
(program discontinued based on GIPF-007 results)
Sponsor:
Information provided by:
InterMune
ClinicalTrials.gov Identifier:
NCT00076635
First received: January 28, 2004
Last updated: November 2, 2007
Last verified: November 2007
  Purpose

Open-label therapy will be administered to up to 220 patients, following completion of either InterMune Protocol GIPF-002 Part B or Protocol GIPF-004, to assess the long-term safety of subcutaneous Interferon gamma-1b. The study duration will be 5 years.


Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Lung Disease
Drug: Interferon gamma-1b
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study of the Safety of Subcutaneous Recombinant Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:


Further study details as provided by InterMune:

Primary Outcome Measures:
  • All adverse events up to the end of study [ Time Frame: 3.5 years ]
  • Survival status at end of study [ Time Frame: 3.5 years ]
  • Serum antibodies to Interferon gamma-1b after the last injection. [ Time Frame: 3.5 years ]

Enrollment: 91
Study Start Date: November 2003
Study Completion Date: April 2007
Intervention Details:
    Drug: Interferon gamma-1b
    200 mcg, SQ, 3x per week
Detailed Description:

Open-label therapy will be administered subcutaneously. Patients enrolled will continue to receive Interferon gamma-1b therapy three times per week and will be evaluated at 6-week intervals. Patients not taking Interferon gamma-1b at enrollment will re-initiate therapy with subcutaneous Interferon gamma-1b under a dose-escalation scheme, reaching full dose after 2 weeks.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Enrollment in Protocol GIPF 002 Part B or GIPF-004
  • Completion of the End of Treatment Visit in Protocol GIPF-002 Part B or the Study Completion Visit in GIPF-004
  • Able to understand and sign a written informed consent form and comply with the requirements of the study

Exclusion criteria:

  • pregnancy or lactation
  • lack of adherence to either GIPF-002 or GIPF-004 study protocols and treatment regimens
  • if Principal Investigator deems patient is unsuitable for study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00076635

Locations
United States, California
Intermune Inc
Brisbane, California, United States, 94005
Sponsors and Collaborators
InterMune
Investigators
Investigator: InterMune, Inc. 888-486-6411 Medical Information
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00076635     History of Changes
Other Study ID Numbers: GIPF-006
Study First Received: January 28, 2004
Last Updated: November 2, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by InterMune:
Idiopathic
Pulmonary
Fibrosis
IPF
Lung
Actimmune
Interferon
Gamma
InterMune

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

ClinicalTrials.gov processed this record on April 22, 2014