A Phase 2 interventional study of PEG-rIL-29 and Peginterferon alfa-2a in Hepatitis C, Chronic, sponsored by ZymoGenetics. Status unknown at 79 sites in 11 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2011-12-05.
Sponsored by ZymoGenetics · Phase 2, Interventional, and Treatment
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 evaluate the safety and antiviral effects of several different doses of PEG-rIL-29 (a man-made form of IL-29) when it is given in combination with daily oral doses of ribavirin (an antiviral drug) to subjects with hepatitis C infection who have received no prior treatment for this disease.
PEG-rIL-29 (also known as PEG-interferon lambda) is a unique Type III interferon molecule that has demonstrated antiviral activity when administered weekly for 4 weeks to treatment-relapsed and treatment-naive subjects with genotype 1 hepatitis C virus (HCV) infection. Because PEG-rIL-29 binds to a unique receptor with a more limited distribution than the receptor for interferon (IFN)-α, it may have the potential to treat HCV without some of the treatment-limiting side effects associated with IFN-α-based therapies. The purpose of this Phase 2a/b randomized, controlled, multicenter study is to compare the safety and efficacy of PEG-rIL-29 and peginterferon alfa-2a, both administered subcutaneously weekly for up to 48 weeks in combination with daily oral ribavirin, in treatment-naive subjects with chronic genotype 1, 2, 3, or 4 HCV infection. The initial part of the study (Phase 2a) will be conducted as an open-label study; the second part of the study (Phase 2b) will be conducted as a blinded study. The above information provided in this listing is specific to the Phase 2b portion of the study. In addition, two small open-label substudies will be conducted to evaluate the efficacy of 24-week treatment with PEG-rIL-29 and ribavirin in subjects with HCV genotype 1 who have a particular genetic polymorphism associated with favorable response (n=60) and to evaluate the efficacy of 16-week treatment with PEG-rIL-29 and ribavirin in subjects with HCV genotype 2 or 3 (n=30).
6,688 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 600 is above the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →ZymoGenetics is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Additional inclusion and exclusion criteria are specified in the protocol.
Drug: PEG-rIL-29 · Drug: Ribavirin
Drug: PEG-rIL-29 · Drug: Ribavirin
Drug: Peginterferon alfa-2a · Drug: Ribavirin
Weekly SC injections in combination with ribavirin for up to 48 weeks
Weekly SC injections in combination with ribavirin for up to 48 weeks
Also known as: PEGASYS
Daily oral administration (400-600 mg BID)
HCV RNA
Time frame: At week 12, week 24, or week 48
Incidence and severity of adverse events
Time frame: Through week 12, week 40, or week 48
Incidence and severity of adverse events and laboratory abnormalities
Time frame: Up to week 72
HCV RNA
Time frame: Up to week 72
PD biomarkers
Time frame: Up to week 72
Quality of life assessments
Time frame: Up to week 72
Serum drug concentration profile
Time frame: Up to week 48
This study is status unknown, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.
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ZymoGenetics