NCT00623649已完成1 期
A Phase 1B, Multicentre, Randomized, Double-Blinded, and PLacebo-Controlled Study of the Antiviral Activity, Safety, Tolerability, and PK of Multiple Ascending Doses of VCH-916 in the Treatment Naive or Experienced Subjects With Chronic Hep C-Infection.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 5
- 主要终点
- The primary objective of this trial is to assess the antiviral activity, safety, and tolerability of VCH-916 monotherapy in adult subjects with chronic HCV-infection.
研究概览
简要总结
The purpose of this study is to determine whether a 3-day course of therapy with orally administered VCH-916 given at different dosages can effectively reduce the amount of circulating virus (i.e., viral load) in patients with early-stage chronic hepatitis C-infection. This study will also evaluate the safety and tolerability of treatment with VCH-916. Blood samples will also be taken to measure the levels of VCH-916 present in plasma at various time points during the treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females 18 to 60 years of age
- •No evidence of cirrhosis or have liver fibrosis corresponding to Metavir Stages 0 to 3
- •Subject's liver disease is stable with ALT values < 5 X ULN
- •Serologic evidence of detectable plasma HCV-RNA of ≥ 100,000 IU/ml at screening
- •Documented HCV Genotype 1 chronic hepatitis C.
- •Judged to be in good health on the basis of medical history and physical examination
- •All other hematology and clinical chemistry must be within normal limits or show no clinically significant abnormalities.
- •Be treatment-naïve or experienced.
- •For female subjects, must not be pregnant or breastfeeding and must be postmenopausal, surgically sterile, abstinent, or using two proven methods of birth control.
- •Sexually active male subjects, must be practicing acceptable methods of contraception during the treatment period
- •Female subjects of childbearing potential must have a negative serum ß-HCG pregnancy test at screening and a negative urine pregnancy test on Day 1 before the first dose of study drugs.
- •Agree not to participate in other clinical trials for the duration of his/her participation in this clinical trial.
排除标准
- •Be participating in any other clinical studies or have participated in another clinical trial within the last 30 days before study drug administration, or participation in more than 2 drug studies in the last 12 months (exclusive of the current study).
- •Be actively taking hard illicit drugs within 12 months prior to the screening visit or alcohol.
- •Have a Child-Pugh score > than
- •Have evidence of liver cirrhosis including histological evidence of hepatic cirrhosis on any liver biopsy.
- •Have any cause of liver disease other than chronic hepatitis C-infection
- •Active or malignant disease or suspicion or history of malignant disease within five previous years (except for adequately treated basal cell carcinoma).
- •Have clinically significant electrocardiogram abnormalities and/or cardiovascular dysfunction within the previous 6 months
- •Have significant renal, pulmonary, gastrointestinal absorption, or neurological diseases, or neoplasia.
- •Have a history of psychiatric disorders determined by the investigator to contraindicate therapy.
- •Have uncontrolled Type 1 or Type II diabetes.
- •Antinuclear antibody titer ≥1:
- •Coinfection with hepatitis B and/or HIV 1 or HIV 2.
研究组 & 干预措施
Cohort 1
Experimental
VCH-916 100 mg three times a day (t.i.d.)
干预措施: VCH 916 (Drug)
Cohort 1
Experimental
VCH-916 100 mg three times a day (t.i.d.)
干预措施: Placebo (Drug)
Cohort 2
Experimental
VCH-916 200 mg (t.i.d.)
干预措施: VCH 916 (Drug)
Cohort 2
Experimental
VCH-916 200 mg (t.i.d.)
干预措施: Placebo (Drug)
Cohort 3
Experimental
VCH-916 300 mg twice daily for three days
干预措施: VCH 916 (Drug)
Cohort 3
Experimental
VCH-916 300 mg twice daily for three days
干预措施: Placebo (Drug)
cohort 4
Experimental
VCH-916 400 mg twice daily for three days
干预措施: VCH 916 (Drug)
cohort 4
Experimental
VCH-916 400 mg twice daily for three days
干预措施: Placebo (Drug)
结局指标
主要结局
The primary objective of this trial is to assess the antiviral activity, safety, and tolerability of VCH-916 monotherapy in adult subjects with chronic HCV-infection.
时间窗: Day 1 to Day 17 visits
次要结局
- To establish the relationship between VCH-916 plasma levels and corresponding HCV RNA reduction with the administered dosages of VCH-916 in adults.(Day 1 to Day 4 visits)
- To study the kinetics of plasma HCV RNA following treatment for up to three(3) days with VCH-916.(Day 1 to Day 4 visits)
- To evaluate the pharmacokinetic (PK) profile of VCH-916 in HCV-infected adults.(Day 1 visit)
研究者
研究点 (5)
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