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

ZymoGenetics56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C, Chronic

Interventions

PEGylated recombinant interleukin 29 (PEG-rIL-29)DRUG

subcutaneous administration either weekly or every other week

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (11)

Northwestern Memorial Hospital

Chicago, Illinois, United States

Henry Ford Health System

Detroit, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Adverse events and standard clinical laboratory abnormalities

Time frame: Day 59

Secondary Outcomes

HCV RNA levels, serum concentrations of PEG-rIL-29, serum beta2-microglobulin (B2M) levels, serum 2'5' oligoadenylate synthetase (OAS) levels, the presence of anti-PEG-rIL-29 antibodies

Time frame: Day 59

Data from ClinicalTrials.gov

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