ACTRN12614000307606已完成2 期
A phase 2, open-label, randomized, controlled, partial crossover study to evaluate the efficacy, safety and tolerability of 8 weeks or 6 weeks of ACH-0143102 and sofosbuvir in treatment-naive subjects with chronic hepatitis C genotype-1 viral infection
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Chronic HCV infection
- •- HCV GT-1
- •- HCV RNA greater than 10,000 IU/mL at screening
- •- Signed and dated written consent
- •- Treatment naive subjects
- •- Biopsy or fibroscan confirming no evidence of cirrhosis
排除标准
- •- BMI greater than 36kg/m2
- •- Pregnant or lactating females. Men whose female partners are pregnant or contemplating pregnancy
- •- Clinically significant laboratory abnormality at screening
- •- Known HIV infection
- •- Positive hepatits B surface antigen
- •- History of participation in a clinical trial with pegylated interferon, RBV, or a direct-acting anti-viral agent, or previous treatment with any of these where at least one dose was taken
- •- Use of dietary supplements, herbal supplements, potent PGP inducers in the intestine, anticonvulsants, antimycobacterials and HIV protease inhibitors.
研究者
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