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

November 2, 2007 updated by: InterMune

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Brisbane, California, United States, 94005
        • Intermune Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InterMune

Investigators

  • InterMune, Inc. 888-486-6411, Medical Information

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

January 28, 2004

First Submitted That Met QC Criteria

January 29, 2004

First Posted (Estimate)

January 30, 2004

Study Record Updates

Last Update Posted (Estimate)

November 6, 2007

Last Update Submitted That Met QC Criteria

November 2, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIPF-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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