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

ClinicalTrials.gov processed this record on October 30, 2014