Evaluation of Efficacy and Safety of Ombitasvir, Paritaprevir, and Ritonavir Plus Ribavirin Based Therapy for Chronic Hepatitis C With or Without Compensated Cirrhosis in Haemodialysis Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Sustained Virological Response
研究概览
简要总结
To evaluate efficacy and safety of Ombitasvir, paritaprevir, and ritonavir plus ribavirin based therapy for chronic hepatitis C with or without compensated cirrhosis in haemodialysis patients.
详细描述
The aim of this study is;
To evaluate the efficacy and safety of ombitasvir, paritaprevir, and ritonavir based therapy for chronic hepatitis C with or without compensated cirrhosis in HCV treatment naïve patients receiving long-term haemodialysis through assessment of:
- The proportion of patients with a sustained virological response (HCV RNA <25 IU/mL) 12 weeks after the last dose of study drug (SVR12).
- To determine withdrawal rate related to side effects and /or adverse effects for patients receiving at least 1 dose of the study medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Under regular HD for at least 6 months
- •Clinically stable condition as outpatients.
- •Treatment naïve patients with serum positive for HCV GT4 with HCV RNA > 1000 IU/ml by PCR.
- •White blood cell count > 2500/mm^
- •Platelet count > 7500/mm^
- •Patients categorised as having compensated cirrhosis had a diagnosis of cirrhosis based on a previous screening liver FibroTest score of 0·72 or lower (eg, Metavir Fibrosis Score >3 [including 3/4 or 3-4] ).
排除标准
- •Confirmed pregnancy.
- •HCV-HIV co infection.
- •HBV-HCV co infection.
- •Uncontrolled hyper or hypothyroidism.
- •For patients without cirrhosis, Patients will be excluded if alanine or aspartate aminotransferase more than five times the upper limit of normal, for patients with cirrhosis they will be excluded if alanine or aspartate aminotransferase are higher than seven times the upper limit of normal
- •Patients on peritoneal dialysis.
研究组 & 干预措施
interventional Qurevo group
A total of 40 HCV treatment naïve patients with or without compensated cirrhosis on regular hemodialysis will be enrolled in the study.
- These patients will receive intervention of '25 mg ombitasvir, 150 mg paritaprevir, and 100 mg ritonavir' (2 capsules Qurevo®) plus ribavirin 200 mg daily for 12 weeks.
- Qurevo will be given once daily (on the day of dialysis, it will be given after dialysis session).
- Ribavirin will be given once daily (on the day of dialysis, it will be given 4 hrs before dialysis session ).
干预措施: Ombitasvir, Paritaprevir and Ritonavir (Drug)
结局指标
主要结局
Sustained Virological Response
时间窗: After 12 weeks after the last dose
The proportion of patients with a sustained virological response (HCV RNA \<25 IU/mL) 12 weeks after the last dose of study drug (SVR12).
次要结局
- Treatment related withdrawal rate(during treatment period, average duration 3 months)
研究者
Mai Mohamed Naguib Abdelmen'em Mohamed
Principle Investigator
Ain Shams University