An Open-Label Study of the Safety of Subcutaneous Recombinant Interferon gamma-1b in Patients with Idiopathic Pulmonary Fibrosis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-001261-17-IE

Enrollment

Unknown

Registered

2004-12-08

Start date

2005-01-28

Completion date

Unknown

Last updated

2020-10-13

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

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Interventions

Trade Name: Immukin Product Name: Interferon gamma-1b Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Enrollment in Protocol GIPF-002 Part B or GIPF-004 2. Completion of the End of Treatment Visit in Protocol GIPF-002 Part B or the Study Completion Visit in GIPF-004 3. Able to understand and sign a written informed consent form and comply with the requirements of the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Pregnancy or lactation 2. Lack of adherence to GIPF-002 or GIPF-004 study protocol and treatment regimen 3. In the opinion of the Principal Investigator (PI), the patient is not a suitable candidate for study participation

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the long-term safety of subcutaneous IFN-g 1b, administered in doses of 200 mg three times per week (tiw) in patients who complete either InterMune Protocol GIPF-002 Part B or GIPF-004.;Secondary Objective: To provide access to IFN-g 1b for patients who have completed these studies.;Primary end point(s):	—

Countries

Ireland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026