CTRI/2017/08/009547招募中4 期
An observational, practice based, open label, prospective, multicenter, post marketingsurveillance to assess safety and efficacy of sofosbuvir as a component of a combinationantiviral treatment regimen for the treatment of patients with chronic hepatitis C (CHC) virusinfection.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Cipla Ltd
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
- •1. A written, signed and dated Data Sharing Informed Consent
- •from all patients/LAR
- •2. Either gender with age 18 years and above
- •3. Patients having confirmed diagnosis of chronic hepatitis C virus
- •infection who are either treatment naïve or with prior treatment
- •experience.
排除标准
- •1. Known hypersensitivity to Sofosbuvir or ribavirin or peginterferon
- •alfa, daclatasvir or any of its components
- •2. Contraindications to Sofosbuvir or any of the components of
- •the combination regimen
- •3. Women who are pregnant or may become pregnant and men
- •whose female partners are pregnant
- •4. Women of child bearing potential who are unwilling to use
- •adequate contraceptive measures unless abstinence is
- •considered adequate in the opinion of the investigator.
- •5. Any other condition as per the discretion of investigator
研究者
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