Efficacy and Safety of Roflumilast in Patients with Non-Alcoholic Steatohepatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Change in liver stiffness measurement (LSM) measured by fibroscan score
研究概览
简要总结
Study type :clinical trial Main purpose :esnsure safety and efficacy of Roflumilast to treat patients with Non-Alcoholic Steatohepatitis Background and aim: Non-alcoholic fatty liver disease is the most prevalent chronic liver disease globally. There is no defined therapy for non-alcholic steatohepatitis (NASH), therefore this study aimed at evaluating the efficacy and safety of Roflumilast in patients with non-alcoholic NASH.
Methods: This randomized controlled parallel study involved 55 patients with NASH who were randomized into vitamin E group or control group (n=24) which received vitamin E 1000 mg once daily and roflumilast group (n=31) which received roflumilast 500 μg once daily for three months.
Patients were assessed at baseline and after intervention through liver stiffness measurement (LSM) using fibro-scan and through evaluation of serum levels of tumor necrosis factor -alpha (TNF-α), Malondialdehyde (MDA), transforming growth factor-beta 1 (TGF-ß1). In addition, liver enzymes, lipid panel, fasting blood glucose and fasting insulin level with subsequent calculation of the homeostatic model assessment for Insulin resistance (HOMA-IR) were also assessed.
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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Cytokeratine level >240 IU/L.
- •Adult patient (age > 18 years old).
- •Both sex.
- •Overweight and obese.
- •Patients with evidence of steatosis through imaging.
- •Patient with mild to moderate elevation in aminotransferase activity (>2 ,but <5 times upper limit of normal ).
- •Patient with Hepatic steatosis index (HSI) >
- •Patient with HAIR ( hypertension ,alanine aminotransferase level ,insulin resistance ) of 2 or
- •Fibroscan score >7Kpa and < 12.5 Kpa (F2 - F3).
排除标准
- •Alcohol consumer and smokers
- •Patients with Wilson's disease and hemochromatosis .
- •Patients with viral hepatitis.
- •Patients with cirrhosis .
- •Patients with inflammatory diseases .
- •Patients with other comorbid disease that elevate transaminases (congestive heart failure and malignancy).
- •Patients on medications that interfere with lipid and carbohydrate metabolism..
- •Patients on stateogenic medications.
- •Pregnancy and lactating women.
- •Females on oral contraceptive pills.
研究组 & 干预措施
Roflumilast group (n=31)
Arm Description: Roflumilast group (n=31) which received roflumilast 500 μg once daily for three months. Patients were assessed at baseline and after intervention through liver stiffness measurement (LSM) using fibro-scan and through evaluation of serum levels of tumor necrosis factor -alpha (TNF-α), Malondialdehyde (MDA), transforming growth factor-beta 1 (TGF-ß1). In addition, liver enzymes, lipid panel, fasting blood glucose and fasting insulin level with subsequent calculation of homeostatic model assessment for Insulin resistance (HOMA-IR) were also assessed.
干预措施: Roflumilast 500 Mcg Oral Tablet (Drug)
Vitamin E group or control group (n=24)
vitamin E group or control group (n=24) which received vitamin E 1000 mg once daily. Patients were assessed at baseline and after intervention through liver stiffness measurement (LSM) using fibro-scan and through evaluation of serum levels of tumor necrosis factor -alpha (TNF-α), Malondialdehyde (MDA), transforming growth factor-beta 1 (TGF-ß1). In addition, liver enzymes, lipid panel, fasting blood glucose and fasting insulin level with subsequent calculation of homeostatic model assessment for Insulin resistance (HOMA-IR) were also assessed.
干预措施: Vitamin E capsule (Drug)
结局指标
主要结局
Change in liver stiffness measurement (LSM) measured by fibroscan score
时间窗: 12 weeks following the end of treatment
Liver Stiffness measurement (LSM) by fibro-scan. Transient elastography (Fibroscan, Echosens, Paris) was used to assess liver stiffness depending up-on the method formerly prescribed .Through a single independent operator, at least ten valid measurements were obtained for each patient. Results were included in the final analysis only if the following three criteria were met: at least ten valid measurements, success rate \>60% and the interquartile range (IQR)-to-liver stiffness ratio was ≤0.30. The median values of the validated measurements for each patient were representative to the liver stiffness and expressed in units of kilopascals (kPa)
次要结局
- The change in liver panel parameters(3 months after treatment)
- Improvement in HOMA IR(12 weeks following the end of treatment)
研究者
Mokhtar Salem Mohamed
Doctor
Tanta University