Overview

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

Status:
Completed
Trial end date:
2009-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ZymoGenetics
Treatments:
Interferons
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