NCT02057887Unknown1 期
Safety,Tolerability and Pharmacokinetic Study of Recombinant Human Interferon Alfa 2B in Chronic Hepatitis C Patients (HM10660A)
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2013年7月最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- HCV RNA Viral load
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of HM10660A in subjects with chronic hepatitis C(HCV).
详细描述
- To evaluate the repeat-dose pharmacokinetics (PK) of HM10660A when given by weekly, biweekly, and monthly subcutaneous (SC) injection.
- To evaluate the repeat-dose pharmacodynamics (PD) of HM10660A when given by weekly, biweekly, and monthly SC injection.
- To explore the antiviral activity of HM10660A at Week 4, Week 12, and Week 24.
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
- •Male or female, aged 18 to 65 years old, inclusive
- •Willing and able to provide written informed consent.
- •Previously untreated HCV infection with HCV RNA > 75,000 IU/mL at screening.
- •HCV genotype 1a or 1b.
- •Body mass index (BMI) between 18 and 38 kg/m
- •Willing and able to comply with the protocol and available to complete the study schedule of assessments.
排除标准
- •Pregnant women or women who may wish to become pregnant during the course of the study.
- •Males and females of reproductive potential who are unwilling to use 2 forms of effective birth control throughout the duration of study treatment and for at least 6 months after the last dose of RBV. One method should include a condom with spermicide for males. Males must agree to refrain from sperm donation for at least 6 months after the last dose of RBV.
- •Evidence of infection or co-infection with a non-genotype 1 HCV strain.
- •Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
- •Lactating females
研究组 & 干预措施
Cohort2
Experimental
HM10660A SC once every 2 weeks
干预措施: HM10660A (Drug)
Cohort3
Experimental
HM10660A SC once every 4 weeks
干预措施: HM10660A (Drug)
Cohort1
Experimental
HM10660A SC once weekly
干预措施: HM10660A (Drug)
Cohort4
Active Comparator
180 mcg Pegasys SC once weekly
干预措施: Pegasys (Drug)
结局指标
主要结局
HCV RNA Viral load
时间窗: Through study week 32
Safety/tolerability
时间窗: Through study week 32
symptom-directed physical examination, Vital signs, Inspection of the Injection site, Complete Physical examination, 12-lead ECG, Hematology/coagulation
次要结局
- Rapid virologic response (RVR)(Study Week 4)
- Sustained virologic response (SVR)(Study week 24)
- Early virologic response (EVR)(Study week 12)
研究者
研究点 (1)
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