CTRI/2010/091/002967已完成2 期
A Multicenter, Randomized, Open Label, Parallel-group Phase IIB Study on the Efficacy and Safety of Oral Regimens of DEB025 Alone or in Combination With Ribavirin Versus Standard of Care (Peg-IFNalpha2a Plus Ribavirin) in Treatment-naïve Hepatitis C Genotype 2 and 3 Patients. - NI
ovartis HealthCare Pvt Ltd0 个研究点目标入组 340 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 340
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Chronic hepatitis C viral
- •Plasma HCV RNA level lower limit ≥ 10000 IU/ml assessed by qPCR (quantitative polymerase chain reaction) or equivalent at screening; no upper limit;
- •HCV genotype 2 or 3;
- •No previous treatment for Hepatitis C infection
排除标准
- •Patients with evidence of Cirrhosis at the time of screening.
- •Patients with evidence of Hepatocellular carcinoma at the time of screening.
- •Any other cause of relevant liver disease other than HCV.
- •4. ALT greater than or equal to 10 times ULN.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究者
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