A Phase 1 Study to Assess the Safety and Antiviral Activity of PEG-rIL-29 Administered as a Single Agent and in Combination With Ribavirin in Treatment-Relapsed and Treatment-Naive Subjects With Chronic Hepatitis C Virus Infection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- ZymoGenetics
- 入组人数
- 56
- 试验地点
- 22
- 主要终点
- Adverse events and standard clinical laboratory abnormalities
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Adverse events and standard clinical laboratory abnormalities
时间窗: Day 59
次要结局
- 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)