Randomized, Controlled Phase 2a/b Study of the Efficacy and Safety of PEG-rIL-29 Administered in Combination With Ribavirin to Treatment-Naive Subjects With Chronic Hepatitis C Virus Infection
试验速览
- 阶段
- 2 期
- 发起方
- ZymoGenetics
- 入组人数
- 600
- 主要终点
- HCV RNA
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 evaluate the safety and antiviral effects of several different doses of PEG-rIL-29 (a man-made form of IL-29) when it is given in combination with daily oral doses of ribavirin (an antiviral drug) to subjects with hepatitis C infection who have received no prior treatment for this disease.
详细描述
PEG-rIL-29 (also known as PEG-interferon lambda) is a unique Type III interferon molecule that has demonstrated antiviral activity when administered weekly for 4 weeks to treatment-relapsed and treatment-naive subjects with genotype 1 hepatitis C virus (HCV) infection. Because PEG-rIL-29 binds to a unique receptor with a more limited distribution than the receptor for interferon (IFN)-α, it may have the potential to treat HCV without some of the treatment-limiting side effects associated with IFN-α-based therapies. The purpose of this Phase 2a/b randomized, controlled, multicenter study is to compare the safety and efficacy of PEG-rIL-29 and peginterferon alfa-2a, both administered subcutaneously weekly for up to 48 weeks in combination with daily oral ribavirin, in treatment-naive subjects with chronic genotype 1, 2, 3, or 4 HCV infection. The initial part of the study (Phase 2a) will be conducted as an open-label study; the second part of the study (Phase 2b) will be conducted as a blinded study. The above information provided in this listing is specific to the Phase 2b portion of the study. In addition, two small open-label substudies will be conducted to evaluate the efficacy of 24-week treatment with PEG-rIL-29 and ribavirin in subjects with HCV genotype 1 who have a particular genetic polymorphism associated with favorable response (n=60) and to evaluate the efficacy of 16-week treatment with PEG-rIL-29 and ribavirin in subjects with HCV genotype 2 or 3 (n=30).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •No prior therapy for chronic HCV, other than up to 2 weeks of single-agent therapy with a direct-acting antiviral agent, including but not limited to, a protease or polymerase inhibitor
- •HCV genotype 1, 2, 3, or 4
- •HCV RNA ≥100,000 IU/mL
- •ALT and AST ≤5.0 × ULN
- •Documented absence of cirrhosis
- •Able to comprehend the investigational nature of this study and sign an informed consent form
排除标准
- •Mixed genotype HCV infection
- •Current or prior history of decompensated liver disease
- •Received any investigational drug, including a direct-acting antiviral agent, within 60 days prior to receiving study drug
- •Positive test for hepatitis B surface antigen, human immunodeficiency virus (HIV)-1, or HIV2 antibody at screening
- •Active substance abuse, such as alcohol, or inhaled or injected drugs, within 6 months
- •Additional inclusion and exclusion criteria are specified in the protocol.
研究组 & 干预措施
PEG-rIL-29 at 180 µg
干预措施: PEG-rIL-29 (Drug)
PEG-rIL-29 at 180 µg
干预措施: Ribavirin (Drug)
PEG-rIL-29 at 120 µg
干预措施: Ribavirin (Drug)
PEG-rIL-29 at 120 µg
干预措施: PEG-rIL-29 (Drug)
Peginterferon alfa-2a at 180 µg
干预措施: Peginterferon alfa-2a (Drug)
Peginterferon alfa-2a at 180 µg
干预措施: Ribavirin (Drug)
结局指标
主要结局
HCV RNA
时间窗: At week 12, week 24, or week 48
Incidence and severity of adverse events
时间窗: Through week 12, week 40, or week 48
次要结局
- Incidence and severity of adverse events and laboratory abnormalities(Up to week 72)
- HCV RNA(Up to week 72)
- PD biomarkers(Up to week 72)
- Quality of life assessments(Up to week 72)
- Serum drug concentration profile(Up to week 48)