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

 -  Relapsed subjects (Parts 1 and 2) -- Prior treatment for HCV with PEG-IFN-alpha (or
 other IFN-alpha) and ribavirin for at least 12 weeks. Naive subjects (Part 3) -- No
 prior treatment with PEG-IFN-alpha (or other IFN-alpha)

 -  Genotype 1 HCV RNA greater than or equal to 100,000 IU/mL. Mixed genotype HCV
 infection is not allowed

 -  Documented liver biopsy ≤2 years of study enrollment with Ishak score ≤4

 -  No evidence of hepatocellular carcinoma documented by abdominal imaging within 12
 months of study entry

 -  no evidence of clinically significant diastolic or systolic dysfunction or other
 clinically significant abnormalities on echocardiogram or ECG

 -  Negative drug and alcohol tests except for physician prescribed or approved medication

 -  If male, or female of child-bearing potential, agrees to use 2 forms of medically
 accepted contraception while on study

 Exclusion Criteria:

 -  Evidence of decompensated liver disease

 -  History of hypersensitivity to IFN-alpha or ribavirin

 -  Active substance abuse, such as alcohol, inhaled or injection drugs within the
 previous 6 months

 -  Undergone surgery or received blood products within 30 days prior to study enrollment

 -  Prior history of cardiomyopathy, coronary artery disease including angina,
 interventive procedure for coronary artery disease including angioplasty, stent
 procedure or cardiac bypass surgery, prior myocardial infarction, or ventricular
 tachycardia

 -  Prior or current history of hemoglobinopathy or hemolytic anemia