study of peg-ril-29 (or peg-ifn lambda) in subjects with chronic hepatitis c virus infection

Conditions: Hepatitis C, Chronic

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.

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.

Eligibility criteria:
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

Keywords: pegylated recombinant interleukin 29 interferon lambda interleukin 29 hepatitis c virus infection liver