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)
Information provided by:
InterMune Identifier:
First received: January 28, 2004
Last updated: November 2, 2007
Last verified: November 2007

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.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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 identifier: NCT00076635

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

No publications provided 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:

Additional relevant MeSH terms:
Idiopathic Interstitial Pneumonias
Idiopathic Pulmonary Fibrosis
Lung Diseases
Pulmonary Fibrosis
Lung Diseases, Interstitial
Pathologic Processes
Respiratory Tract Diseases
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses processed this record on October 09, 2015