Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

January 28, 2004
November 2, 2007
November 2003
Not Provided
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00076635 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
An Open-Label Study of the Safety of Interferon Gamma-1b in Patients With IPF
An Open-Label Study of the Safety of Subcutaneous Recombinant Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis

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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Idiopathic Pulmonary Fibrosis
  • Pulmonary Fibrosis
  • Lung Disease
Drug: Interferon gamma-1b
200 mcg, SQ, 3x per week
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
91
April 2007
Not Provided

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00076635
GIPF-006
No
Not Provided
InterMune
Not Provided
Investigator: InterMune, Inc. 888-486-6411 Medical Information
InterMune
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP