Study to Evaluate the Possible Antifibrotic Effect of Zinc Sulphate in Chronic HCV Patient Receiving Direct Acting Anti-viral Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Serum hyaluronic acid level
研究概览
简要总结
This study aims to evaluate the possible antifibrotic effect of zinc sulphate in chronic HCV patient receiving direct acting anti-viral therapy
详细描述
Chronic infection with hepatitis C virus (HCV) is a leading cause of liver-related morbidity and mortality worldwide and predisposes to liver fibrosis and end-stage liver complications. Liver fibrosis is the excessive accumulation of extracellular matrix proteins, including collagen, and is considered as a wound healing response to chronic liver injury.
Removal or elimination of the causative agent such as control or cure of viral infection has shown that liver fibrosis is reversible. Thus, there is a huge unmet medical need for anti-fibrotic therapies to prevent liver disease progression and Hepatocellular Carcinoma (HCC) development. However, while many anti-fibrotic candidate agents have shown robust effects in experimental animal models, but uptill now, no approved therapy exists for liver fibrosis.
The once-daily oral combination of Daclatasvir 60 mg and Sofosbuvir 400 mg once daily, for the treatment of non-cirrhotic naïve patients with chronic hepatitis C virus genotype 4 infection for 12 weeks, is effective and well tolerated in these patients.
Zinc, an essential trace element, is involved in the enzymatic activities and structural maintenance of numerous enzymes and proteins, and it has various physiological roles in the body. Specifically, zinc works as a growth factor and exerts immunomodulatory , antioxidant, anti-apoptotic and anti-inflammatory effects.
Zinc deficiency is prevalent in cirrhosis patients, whereas nitrogen metabolic disorders, particularly hypoalbuminemia, can be an indicator of zinc deficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patients with fibrosis stage (F1&F2) post chronic HCV infection.
- •Age > 18 and < 65 years.
排除标准
- •Patients with prior history of liver transplantation.
- •Patients with prior history of hepatocellular carcinoma.
- •Patients coinfected with HIV or HBV.
- •Patients with any malignancies.
- •Pregnant and lactating women.
研究组 & 干预措施
Group 2
25 patients will receive 50mg Zinc Sulphate plus the standard direct acting anti-viral therapy for 3 months.
干预措施: Zinc Supplement (Drug)
结局指标
主要结局
Serum hyaluronic acid level
时间窗: 3 months
Hyaluronic acid is a chief component of the extracellular matrix (ECM) of connective tissues and The most important organ involved in the synthesis of hyaluronic acid is the liver
Abdominal Ultrasonography
时间窗: 3 months
Assessment the change in the degree of liver fibrosis post treatment and compare their results before and post treatment
Serum fibronectin level
时间窗: 3 months
Fibronectin (FN), which is produced by hepatic stellate cells (HSCs), participates in cell adhesion and proliferation, and has an important role in fibrotic progression, excessive FN deposition occurs prior to collagen deposition
Serum transforming growth factor - beta 1 (TGF- β1) level
时间窗: 3 months
Transforming growth factor (TGF)-β is a good noninvasive marker for the assessment of liver fibrosis in patients with chronic HCV and also considered as a master profibrogenic cytokine and a promising target to treat fibrosis (15)
AST to Platelet Ratio Index (APRI) score
时间窗: 3 months
The APRI model was developed as a simple, easily calculated method to predict significant, severe fibrosis (or cirrhosis) and has been tested in persons with HCV mono-infection and those with HCV and HIV Co-infection APRI = (AST Level /AST (Upper Limit of Normal))/(Platelet Count (〖10〗\^9/L) )X100 If the score is less than or equal to 0.5, the liver is either completely free of fibrosis (F0), or has a tiny bit of scarring (F1 or F2 by METAVIR Score). If the score is 1.5 or greater, the liver has scarring and likely some cirrhosis (F3 or F4 by METAVIR Score)
Fibrosis-4 (FIB-4) Score
时间窗: 3 months
The Fibrosis 4 score is a non-invasive scoring system based on several laboratory tests (AST/ALT/Platelets) that help to non-invasively estimate the amount of scarring in the liver. This score has been studied in liver disease due to Hepatitis C and Non-alcoholic steatohepatitis (NASH) FIB-4 = (Age (years)XAST Level (U/L))/(Platelet Count (〖10〗\^9/L) X √(ALT (U/L))) FIB-4\>3.25 confirms the presence of advanced fibrosis (F4) FIB-4\<1.45 exclude the presence of advanced fibrosis (F3-F4) Values between 1.45 and 3.25 did not fully discriminate fibrosis and would need an additional method to predict liver fibrosis
次要结局
未报告次要终点
研究者
Dina Samir Ahmed Attalla
Pharmacist
Tanta University