A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of ANA598 Administered With Pegylated Interferon and Ribavirin in Genotype 1 Patients With Chronic Hepatitis C Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 283
- 主要终点
- Proportion of patients achieving sustained virologic response (SVR24), defined as undetectable hepatitis C virus (HCV) RNA at 24 weeks after discontinuation of all study drugs
研究概览
简要总结
This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of setrobuvir in patients with genotype 1 chronic hepatitis C. Treatment-naïve patients will be randomized to receive either setrobuvir (800 mg orally b.i.d loading dose followed by 200 mg orally .b.i.d.) or placebo in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Treatment duration will be 28 weeks or 48 weeks depending on response. Treatment-experienced patients categorized as relapsers, partial responders and viral breakthrough patients to previous pegylated interferon and ribavirin therapy will be randomized to receive either setrobuvir or placebo in combination with Pegasys and Copegus for 48 weeks. Treatment-experienced patients categorized as null-responders to previous pegylated interferon and ribavirin therapy will be assigned to treatment with setrobuvir plus Pegasys and Copegus for 48 weeks.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, 18 to 65 years of age inclusive
- •Documented chronic hepatitis C
- •Treatment-naïve (no prior exposure to Pegasys, Copegus, or experimental HCV therapy) or treatment-experienced with current standard of care (Pegasys and Copegus) but categorized as null-responder or patients with partial response, relapse or viral breakthrough during or following prior treatment
- •Serum HCV RNA >/= 50,000 IU/mL at screening
- •HCV antibody positive at screening
- •HCV genotype 1
- •Body mass index (BMI) 18-38 kg/m2
- •In good health other than chronic HCV infection in the judgment of the principal investigators
- •Negative for hepatitis B and HIV infection
排除标准
- •Pregnant or breastfeeding women
- •For treatment-naïve patients: any previous treatment for HCV infection
- •For treatment-experienced patients: previous treatment with an experimental therapy for HCV infection
- •Co-infection with HIV or hepatitis C virus (HBV)
- •History or evidence of decompensated liver disease
- •History or evidence of hepatocellular carcinoma
- •History of alcohol abuse and/or other drug addiction </= 1 year prior to enrollment in the study
- •Poorly controlled diabetes mellitus
- •One or more additional known primary causes of liver disease other than hepatitis C
- •History of acute or chronic pancreatitis
- •Participation in an other clinical study of a new chemical entity within 30 days prior to study randomization
研究组 & 干预措施
Active Comparator
Pplacebo in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin)
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
Active Comparator
Pplacebo in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin)
干预措施: placebo (Drug)
Active Comparator
Pplacebo in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin)
干预措施: ribavirin [Copegus] (Drug)
Setrobuvir
Setrobuvir (800 mg orally b.i.d loading dose followed by 200 mg orally .b.i.d.) in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin)
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
Setrobuvir
Setrobuvir (800 mg orally b.i.d loading dose followed by 200 mg orally .b.i.d.) in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin)
干预措施: ribavirin [Copegus] (Drug)
Setrobuvir
Setrobuvir (800 mg orally b.i.d loading dose followed by 200 mg orally .b.i.d.) in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin)
干预措施: setrobuvir (Drug)
结局指标
主要结局
Proportion of patients achieving sustained virologic response (SVR24), defined as undetectable hepatitis C virus (HCV) RNA at 24 weeks after discontinuation of all study drugs
时间窗: 24 weeks after discontinuation of all study drugs (treatment duration 28 or 48 weeks)
次要结局
- Proportion of treatment-naïve patients eligible to stop all treatment at Week 28(28 weeks)
- Safety: Incidence of adverse events(up to approximately 72 weeks)
- Proportion of patients achieving undetectable HCV RNA (defined as HCV RNA < 15 IU/mL) at each visit through Week 24(24 weeks)