Study of PEG-rIL-29 (or PEG-IFN Lambda) in Subjects With Chronic Hepatitis C Virus Infection
Completed · Phase 1
Conditions studied: Hepatitis C, Chronic
In brief
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.
Key facts
- Study ID
- NCT00565539
- Run by
- ZymoGenetics
- People needed
- 56
- Starts
- 2007-12-01
- Expected to finish
- 2009-10-01
- Last updated by the study team
- 2009-10-07
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
- London Health Sciences Center — London, Ontario, Canada
Full record on ClinicalTrials.gov
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