Study of PEG-rIL-29 (or PEG-IFN Lambda) in Subjects With Chronic Hepatitis C Virus Infection
- Conditions
- Hepatitis C, Chronic
- Registration Number
- NCT00565539
- Lead Sponsor
- ZymoGenetics
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Adverse events and standard clinical laboratory abnormalities Day 59
- Secondary Outcome Measures
Name Time Method 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 Day 59
Trial Locations
- Locations (11)
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University Hospital (UMDNJ)
🇺🇸Newark, New Jersey, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Michael E. DeBakey Veterans Affairs Medical Center, Baylor College of Medicine
🇺🇸Houston, Texas, United States
St. Luke's Advanced Liver Therapies
🇺🇸Houston, Texas, United States
Alamo Medical Research
🇺🇸San Antonio, Texas, United States
VCUHS Hepatology Research Division
🇺🇸Richmond, Virginia, United States
Scroll for more (1 remaining)Northwestern Memorial Hospital🇺🇸Chicago, Illinois, United States