A Phase 1b/2a, Open-label,Randomized, Safety, Tolerability, Dose Finding, PK/PD, and Preliminary Efficacy Study of Subcutaneous Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- HCV RNA level
研究概览
简要总结
This is an open-label, randomized, safety, tolerability, dose-finding, PK/PD, and preliminary efficacy study of subcutaneous Hanferon™ in combination with ribavirin(RBV) in treatment-naïve subjects with genotype 1 hepatitis C.
详细描述
The primary objective of this study is to evaluate the safety and tolerability of ascending doses of Hanferon™ in combination with ribavirin (RBV).
The secondary objective of this study is to define the PK and PD of ascending doses of Hanferon™ in combination with ribavirin(RBV). The exploratory objective of this study is to make a preliminary assessment of Hanferon™ efficacy in combination with ribavirin(RBV).
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
- None
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
- •Diagnosis of chronic hepatitis C genotype 1a or 1b
- •Male or female aged 18 to 65 years, inclusive
- •Compensated liver disease without evidence of cirrhosis
- •No evidence of type 1 or 2 diabetes mellitus, lipodystrophy or polycystic ovary syndrome
- •No history or presence of autoimmune or lymphoproliferative disease or hemoglobinopathies
- •Stable medication doses for 1 month for the chronic disease if subjects have chronic diseases, including but not limited to hypertension and dyslipidemia
排除标准
- •History of previous treatment of hepatitis C
- •Currently use medication for psychiatric illness including depression, suicidal ideation, and psychosis
- •History or presence of chronic liver disease
- •History of drug or alcohol abuse within the past year
- •Evidence of active illicit drug use
- •Clinically significant abnormal electrocardiogram (ECG) or rhythm strip
- •Female subject who has a positive urine pregnancy test or who is lactating
研究组 & 干预措施
Hanferon (low dose) sc weekly + ribavirin(RBV) oral daily
Hanferon™ 30 μg SC weekly + ribavirin(RBV)1000 mg daily (body weight < 75kg) or ribavirin(RBV) 1200 mg daily (body weight ≥ 75 kg)
干预措施: recombinant variant of interferon-alpha 2b (Drug)
Hanferon (low dose) sc weekly + ribavirin(RBV) oral daily
Hanferon™ 30 μg SC weekly + ribavirin(RBV)1000 mg daily (body weight < 75kg) or ribavirin(RBV) 1200 mg daily (body weight ≥ 75 kg)
干预措施: Ribavirin (Drug)
Hanferon (high dose) sc weekly + ribavirin(RBV) oral daily
Hanferon™ 60 μg SC weekly + ribavirin(RBV) 1000 mg daily (body weight < 75kg) or ribavirin(RBV) 1200 mg daily (body weight ≥ 75 kg)
干预措施: recombinant variant of interferon-alpha 2b (Drug)
Hanferon (high dose) sc weekly + ribavirin(RBV) oral daily
Hanferon™ 60 μg SC weekly + ribavirin(RBV) 1000 mg daily (body weight < 75kg) or ribavirin(RBV) 1200 mg daily (body weight ≥ 75 kg)
干预措施: Ribavirin (Drug)
Pegasys 180 ug sc weekly + RBV oral daily
Pegasys® 180 μg SC weekly + ribavirin(RBV) 1000 mg daily (body weight < 75kg) or ribavirin(RBV) 1200 mg daily (body weight ≥ 75 kg)
干预措施: Peginterferon alfa-2a (Drug)
Pegasys 180 ug sc weekly + RBV oral daily
Pegasys® 180 μg SC weekly + ribavirin(RBV) 1000 mg daily (body weight < 75kg) or ribavirin(RBV) 1200 mg daily (body weight ≥ 75 kg)
干预措施: Ribavirin (Drug)
结局指标
主要结局
HCV RNA level
时间窗: Week 4
次要结局
- Proportion of patients who reach RVR(Week 4)
- PK & PD(Weeks 0 and 3)