Effectiveness and Safety of Pentoxifylline in Treatment of Patients With Nonalcoholic Steatohepatitis
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
- NAFLD fibrosis score (NFS)
研究概览
简要总结
The aim of the present study is to evaluate the efficacy and safety of pentoxifylline in the treatment of non-alcoholic steatohepatitis patients.
详细描述
Nonalcoholic steatohepatitis(NASH) is the progressive form of Non-alcoholic fatty liver disease (NAFLD), is characterized by hepatocellular damage, inflammation, and liver fibrosis that can progress to cirrhosis, in 25% of patients, NAFLD progresses to NASH, which increases the risk for the development of cirrhosis, liver failure, and hepatocellular carcinoma. In patients with NASH, liver fibrosis is the main determinant of mortality.
Pentoxifylline (PTX) is a xanthine derivative drug with a wide range of actions at the cellular and molecular level. PTX possess anti-inflammatory, antioxidant activities. PTX have potential role in improvement of NASH . Also, PTX inhibits a number of pro-inflammatory cytokines including interleukin-1, interleukin-6 and tumor necrosis factor (TNF-α ) which play an important role in the pathogenesis and progression of NASH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18- 60 years old.
- •Patients who have nonalcoholic steatohepatitis (NASH) will be diagnosed by
- •clinical examination (obese, high body mass index).
- •radiological criteria of fatty liver (abdominal ultrasonography).
- •laboratory investigation (elevated liver enzymes aspartate transaminase (AST), alanine transaminase (ALT).
- •The ability to give informed consent
- •Appropriate exclusion of other liver diseases
排除标准
- •1- Patients with other diagnosed chronic liver diseases as viral hepatitis, metabolic and genetic disorders as Hemochromatosis, Wilson disease, autoimmune hepatitis and drug induced liver disease as well as patients with recent infection and those who refused to be entitled in the study.
- •Patients will be excluded if they had a history of past excessive alcohol drinking for a period longer than 2 years at any time in the past 10 years.
- •Patients also will be excluded if they take medications known to cause steatosis or taking medications that have shown benefits in previous NASH pilot studies, including vitamin E, , thiazolidinedione, and alpha-glucosidase inhibitors.
- •Patients with a history of hypersensitivity to PTX or the methylxanthines (caffeine, theophylline, and theobromine) will be excluded, as well as those with a history of cerebral
研究组 & 干预措施
Pentoxifylline Group
25 patients will receive pentoxifylline (Trental SR®) 400 mg three times daily with their standard therapy for 6 months.
干预措施: pentoxifylline (Trental SR®) (Drug)
结局指标
主要结局
NAFLD fibrosis score (NFS)
时间窗: 6 months compared to the baseline
Change in NAFLD fibrosis score (NFS) (lower score means better outcome).
improvement in liver aminotransferases(ALT and AST)
时间窗: 6 months compared to the baseline
Difference between last and first measurements
次要结局
- Change in anthropometric measures(6 months compared to the baseline)
- Drugs adverse events(6 months compared to the baseline)
- Serum Gamma-glutamyl Transferase level (GGT)(6 months compared to the baseline)
- Waist circumference(6 months compared to the baseline)
- Fasting blood glucose level(6 months compared to the baseline)
- The Aspartate (AST) to Platelet Ratio Index (APRI) score:(6 months compared to the baseline)
- The Fibrosis-4 (FIB-4) values:(6 months compared to the baseline)
- Serum total and direct bilirubin.(6 months compared to the baseline)
- Lipid profile(6 months compared to the baseline)
- Glycated hemoglobin (HbA1C)(6 months compared to the baseline)
- Serum Alkaline Phosphatase level (ALP)(6 months compared to the baseline)
研究者
ahmed salah saad abomandour
Principal Investigator
Al-Azhar University