Determining the Sustained Virologic Response of Declatasvir in Egyptian Patients With Hepatitis C Virus Genotype 4

Zagazig University0 个研究点目标入组 250 人开始时间: 2017年11月1日最近更新: 2017年10月10日

适应症

干预措施

试验速览

阶段: 不适用
发起方: Zagazig University
入组人数: 250
主要终点: Efficacy measured by Sustained Virologic Response Rate

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This is a prospective, cohort study in Faculty of Medicine, Zagazig University, Egypt. From June to December, 2016, investigators will follow up patients with chronic Hepatitis C virus genotype 4 receiving daclatasvir-sofosbuvir treatment regimen within the national program of Egyptian ministry of health and population. The primary outcomes are safety of the treatment and the sustained virologic response 12 weeks after discontinuation of therapy. For the secondary outcomes, investigators will measure the change in health related quality of life and investigate the genetic sequence of viral RNA of resistant patients.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients with HCV genotype 4
•Age ≥ 18 years
•HCV RNA≥ 104 IU/mL
•Screening ECG without clinically significant abnormalities.

排除标准

•Total serum bilirubin > 3 mg/dl.
•Serum albumin < 2.8 g/dl.
•INR ≥ 1.7
•Platelet count < 50000/mm
•Hepatic cell carcinoma except four weeks after intervention aiming to cure with no evidence of activity by dynamic imaging (CT or MRI).
•Extra hepatic malignancy except after two years of disease free interval
•Pregnancy or inability to use contraception.
•Inadequately controlled diabetes mellitus (HbA1c > 9%).

研究组 & 干预措施

Group 1: Easy to treat group

Treatment naïve
Total serum bilirubin ≤ 1.2 mg/dl
Serum albumin ≥ 3.5 g/dl
International normalized ratio ≤ 1.2
Platelet count ≥ 150000 mm3

This group will be receiving Sofosbuvir + daclatasvir for 12 weeks.

干预措施: Daclatasvir 60 MG Oral Tablet [Daklinza] (Drug)

Group 1: Easy to treat group

Treatment naïve
Total serum bilirubin ≤ 1.2 mg/dl
Serum albumin ≥ 3.5 g/dl
International normalized ratio ≤ 1.2
Platelet count ≥ 150000 mm3

This group will be receiving Sofosbuvir + daclatasvir for 12 weeks.

干预措施: Sofosbuvir 400 MG Oral Tablet [Sovaldi] (Drug)

Group 2: Difficult to treat group

Peg interferon treatment experienced.
Total serum bilirubin ≥ 1.2 mg/dl
Serum albumin ≤ 3.5 g/dl
International normalized ratio ≥ 1.2
Platelet count ≤ 150000 mm3

This group will be receiving Sofosbuvir + daclatasvir + ribavirin for 12 weeks.

干预措施: Daclatasvir 60 MG Oral Tablet [Daklinza] (Drug)

Group 2: Difficult to treat group

Peg interferon treatment experienced.
Total serum bilirubin ≥ 1.2 mg/dl
Serum albumin ≤ 3.5 g/dl
International normalized ratio ≥ 1.2
Platelet count ≤ 150000 mm3

This group will be receiving Sofosbuvir + daclatasvir + ribavirin for 12 weeks.

干预措施: Sofosbuvir 400 MG Oral Tablet [Sovaldi] (Drug)

Group 2: Difficult to treat group

Peg interferon treatment experienced.
Total serum bilirubin ≥ 1.2 mg/dl
Serum albumin ≤ 3.5 g/dl
International normalized ratio ≥ 1.2
Platelet count ≤ 150000 mm3

This group will be receiving Sofosbuvir + daclatasvir + ribavirin for 12 weeks.

干预措施: Ribavirin Oral Product (Drug)

Group 3: Sofosbuvir resistant cases

This is the group of patients who failed in previous Sofosbuvir treatment regiment. This group will be receiving Sofosbuvir + daclatasvir + ribavirin for 24 weeks.

干预措施: Daclatasvir 60 MG Oral Tablet [Daklinza] (Drug)

Group 3: Sofosbuvir resistant cases

This is the group of patients who failed in previous Sofosbuvir treatment regiment. This group will be receiving Sofosbuvir + daclatasvir + ribavirin for 24 weeks.

干预措施: Sofosbuvir 400 MG Oral Tablet [Sovaldi] (Drug)

Group 3: Sofosbuvir resistant cases

This is the group of patients who failed in previous Sofosbuvir treatment regiment. This group will be receiving Sofosbuvir + daclatasvir + ribavirin for 24 weeks.

干预措施: Ribavirin Oral Product (Drug)

结局指标