NCT00076635

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2003

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2004

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

November 6, 2007

Status Verified

November 1, 2007

First QC Date

January 28, 2004

Last Update Submit

November 2, 2007

Conditions

Idiopathic Pulmonary FibrosisPulmonary FibrosisLung Disease

Keywords

IdiopathicPulmonaryFibrosisIPFLungActimmuneInterferonGammaInterMune

Outcome Measures

Primary Outcomes (3)

  • All adverse events up to the end of study

    3.5 years

  • Survival status at end of study

    3.5 years

  • Serum antibodies to Interferon gamma-1b after the last injection.

    3.5 years

Interventions

Interferon gamma-1bDRUG

200 mcg, SQ, 3x per week

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intermune Inc

Brisbane, California, 94005, United States

Location

MeSH Terms

Conditions

Idiopathic Pulmonary FibrosisPulmonary FibrosisLung DiseasesFibrosis

Interventions

interferon gamma-1b

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • InterMune, Inc. 888-486-6411

    Medical Information

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 28, 2004

First Posted

January 30, 2004

Study Start

November 1, 2003

Study Completion

April 1, 2007

Last Updated

November 6, 2007

Record last verified: 2007-11

Locations

US(1)