CTRI/2018/03/012297尚未招募4 期
An open label, multicenter, Phase-IV clinical trial to evaluate the safety and efficacy of Daclatasvir and Sofosbuvir in patients with Chronic Hepatitis C genotype 3 infection.
ATCO Pharma Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •Patients aged between 19 and 60 years, both ages inclusive.
- •Confirmed chronic HCV with genotype 3 infection (positive HCV genotyping test).
- •Patients with following haematological and biochemical laboratory variables:
- •A neutrophil count of 1.5 x 109/L, haemoglobin concentration of 11 g/dl or higher in women or 12 g/dl or higher in men, a platelet count of greater than 90 x 109/L, total bilirubin within two times the upper limit of normal (21 µmol/L), ALT less than or equal to 10 times the upper limit of normal (ULN), AST less than or is equal to 10 times the ULN.
- •Patients who are willing and able to provide written informed consent.
- •Patients must follow adequate birth control measures from date of screening to at least 7 months from the date of stopping.
排除标准
- •Patients with Hepatocellular Carcinoma
- •Patients who are pregnant or lactating.
- •Patients diagnosed with HIV- I & II, Hepatitis B Virus infection, psychiatric illness, unstable pulmonary or cardiac disease, seizure disorder or other serious comorbid disorders will not be included.
- •Patients with Decompensated Cirrhosis will be excluded.
- •Patients with Creatinine clearance less than 30 mL per minute will be excluded.
研究者
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