ACTRN12619000054112招募中4 期
A pharmacokinetic (PK) study of directly acting antiviral therapy for hepatitis C in pregnancy
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 10
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- Female
入选标准
- •Pregnant women mono-infected with hepatitis C, able to provide written, informed consent, will need to be able to provide contact details, have any HCV genotype with a detectable HCV RNA viral load at screening >1000 IU/ml, a gestational age of 22 weeks at enrollment and a singleton pregnancy with no known fetal anomalies (as confirmed on routine 18-22 week ultrasound).
排除标准
- •Women will be excluded from the study if they have previously had treatment for HCV with a NS5A inhibitor, use of any medications contraindicated with SOF/VEL, have a history of cirrhosis, have any significant uncontrolled active or chronic cardiovascular, renal, or liver disease, haematological, neurological, immunological or infectious disease (other than HCV), have a high risk of preterm birth (defined as a history of preterm birth at less than 34 weeks or a shortened cervical length of less than 20 millimeters).
研究者
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