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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00076635

Enrollment

Registered

2004-01-30

Start date

2003-11-30

Completion date

2007-04-30

Last updated

2007-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis, Lung Disease, Pulmonary Fibrosis

Keywords

Idiopathic, Pulmonary, Fibrosis, IPF, Lung, Actimmune, Interferon, Gamma, InterMune

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.

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.

Interventions

DRUGInterferon gamma-1b

200 mcg, SQ, 3x per week

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026