Association of Serum Interleukin -6 and Transforming Growth Factor Beta Levels With Response to Antiviral Therapy for Chronic Hepatitis c Patients
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- mean difference in level of interleukin-6 and transforming growth factor beta after treatment
研究概览
简要总结
Hepatitis C virus (HCV) infection is associated with significant morbidity and mortality owing to progression of a high percentage (85%) of HCV infected patients to chronic hepatitis, which might lead to the development of liver cirrhosis or hepato cellular carcinoma..
Egypt has possibly the highest HCV prevalence in the world, 10-20% of the general population .
详细描述
Currently, second-generation direct-acting antiviral agents have been used for chronic hepatitis C treatment. The association of sofosbuvir with daclatasvir or simeprevir , with or without ribavirin , directly inhibits viral replication .
Sofosbuvir (400 mg once per day) and daclatasvir (60mg once per day) or simeprevir (150 mg once per day) for 3 months treatment regimens.
Sofosbuvir-based antiviral therapy guarantees efficacy in HCV eradication in approximately 90% of cases and is associated with mild to moderate adverse effects.
Overall, studies describe an increase in serum cytokine levels in chronic hepatitis C patients, when compared with healthy individuals. ,interleukin-6(IL-6) is produced mainly by kupffer cells and induces the production of the acute phase proteins, C-reactive protein and haptoglobin .
Previous studies reported that serum Interleukin-6 levels were increased, compared with healthy individuals, in patients with some liver diseases.Previous results suggest that baseline levels of Interleukin, as well as their decrease during treatment .Transforming growth factor beta (TGF-β) is a cytokine that has been assigned a key role in epithelial repair. Injury to the liver elicits a rapid increase in its expression. HCV -infected hepatocytes produce (TGF-β) which may stimulate T-regulatory cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Age from 18 to 70 years.
- •HCV RNA positivity .
- •Any Body Mass Index(BMI).
- •Treatment-naive or treatment experienced.
- •all fibrosis stages.
- •Exclusion criteria:
- •Direct serum bilirubin greater than 2 mg/dl.
- •Serum albumin less than 2.8 g/dl.
- •International normalization ratio (INR) greater than or equal to 1.7
- •Platelet count less than 50 000/mm
- •Ascites or history of ascites.
- •Hepatic encephalopathy or history of hepatic encephalopathy.
- •Hepatocellular carcinoma.
- •Serum creatinine greater than 2.5 mg/dl .
- •Pregnancy.
排除标准
- 未提供
研究组 & 干预措施
group2 (sustained responder)
Assess serum level of interleukin-6 and transforming growth factor beta after three months from the end of treatment Sofosbuvir (SOF) (400 mg once per day) and daclatasvir (DCV)(60mg once per day) or simeprevir (SIM) (150 mg once per day) for 3 months treatment regimens
干预措施: sofosbuvir and daclatasvir (Drug)
结局指标
主要结局
mean difference in level of interleukin-6 and transforming growth factor beta after treatment
时间窗: three months from the end of treatment
serum level of interleukin-6 and transforming growth factor beta will be measured before and after treatment
次要结局
未报告次要终点
研究者
Hayam Hamdy Mahmoud
principle investigator
Assiut University