NCT00565539

Study of PEG-rIL-29 (or PEG-IFN Lambda) in Subjects With Chronic Hepatitis C Virus Infection

A Phase 1 Study to Assess the Safety and Antiviral Activity of PEG-rIL-29 Administered as a Single Agent and in Combination With Ribavirin in Treatment-Relapsed and Treatment-Naive Subjects With Chronic Hepatitis C Virus Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: ZymoGenetics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Interleukin 29 (IL-29) is a substance that is produced in the body to help fight viral infections. The purpose of this study is to test the safety and antiviral effects of PEG-rIL-29 (a man-made form of IL-29) when it is given either by itself at different doses or in combination with the approved dose of ribavirin (an antiviral drug) to subjects with hepatitis C infection who have received no prior treatment for this disease or who have relapsed following previous treatment with PEGylated interferon alpha (PEG-IFN-α), or other form of IFN-α, and ribavirin.

Detailed description

This is a 3-part study of PEG-rIL-29 in subjects with chronic genotype 1 hepatitis C virus infection who have either received no prior treatment with a PEGylated IFN-α (or other form of IFN-α) or who have relapsed following prior treatment with a PEGylated IFN-α (or other form of IFN-α) and ribavirin. Part 1 of the study will evaluate the safety and tolerability of escalating doses of PEG-rIL-29 when given as a single agent either every other week or weekly over a 4-week period to treatment-relapsed subjects. Part 2 of the study will evaluate dose levels and/or schedules of PEG-rIL-29 in combination with daily oral ribavirin administered over a 4-week period to treatment-relapsed subjects. Part 3 of the study will evaluate dose levels and/or schedules of PEG-rIL-29 in combination with daily oral ribavirin administered over a 4-week period to subjects who have received no prior treatment.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	PEGylated recombinant interleukin 29 (PEG-rIL-29)	subcutaneous administration either weekly or every other week

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2007-11-30
• Last updated: 2009-10-07

Locations

11 sites across 2 countries: United States, Canada