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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2007-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Idiopathic Pulmonary Fibrosis Pulmonary Fibrosis Lung Disease

Keywords

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Idiopathic Pulmonary Fibrosis IPF Lung Actimmune Interferon Gamma InterMune

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Interferon gamma-1b

200 mcg, SQ, 3x per week

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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InterMune, Inc. 888-486-6411

Role:

Medical Information

Locations

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Intermune Inc

Brisbane, California, United States

Site Status

Countries

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United States

Other Identifiers

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GIPF-006

Identifier Type: -

Identifier Source: org_study_id