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

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00076635
• Other study ID #: GIPF-006
• Status: Terminated
• Phase: Phase 3
• First received: January 28, 2004
• Last updated: November 2, 2007
• Start date: November 2003
• Est. completion date: April 2007

Study information

• Verified date: November 2007
• Source: InterMune
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 91
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Lung Disease
• Lung Diseases
• Pulmonary Fibrosis

Intervention

Drug:
• Interferon gamma-1b
200 mcg, SQ, 3x per week

Locations

Country	Name	City	State
United States	Intermune Inc	Brisbane	California

Sponsors (1)

Lead Sponsor	Collaborator
InterMune

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All adverse events up to the end of study		3.5 years
Primary	Survival status at end of study		3.5 years
Primary	Serum antibodies to Interferon gamma-1b after the last injection.		3.5 years