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

Phase 3TerminatedNCT00076635

InterMune91 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Idiopathic Pulmonary Fibrosis Pulmonary Fibrosis Lung Disease

Interventions

Interferon gamma-1bDRUG

200 mcg, SQ, 3x per week

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Intermune Inc

Brisbane, California, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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