NCT03604016Unknown4 期
Pilot Study to Assess the Antiviral Activity and Safety of Besifovir Dipivoxil 150mg and L-carnitine 660mg Compared to Tenofovir Alafenamide 25mg in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 76
- 主要终点
- The rate of subjects who showed HBV DNA undetected (less than 116 copies/mL (20 IU/mL)) at the 48 week
研究概览
简要总结
Pilot study to assess the antiviral activity and safety of Besifovir dipivoxil 150mg and L-carnitine 660mg compared to Tenofovir Alafenamide 25mg in chronic hepatitis B patients with Nonalcoholic fatty liver
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 years of age and older, Male or female patients
- •Chronic hepatitis B patients with Nonalcoholic fatty liver
- •Patients who use oral anti-diabetic drug or drugs for hyperlipemia without any change in drug dosage within 2 month before screening visit
- •Patients who have been explained about the trial and agreed to the consent
- •Patients who agree with the approved method of contraception during the clinical trial
排除标准
- •Patients with hepatitis C virus, hepatitis D virus or human immunodeficiency virus
- •Patients who has a history of liver transplantation or Child-Pugh score >=8
- •Alpha-fetoprotein (AFP) > 50 ng/mL or Hepatocellular Carcinoma (HCC) patients
- •Patients who have taken Besifovir or Vemlidy
- •Among the patients treated with immunosuppressive drug within 6 months before screening, suspected case of the declined immunity in the opinion of the investigator
- •Chronic alcoholism (Significant alcohol consumption: male > 210 g/week, female> 140 g/week)
- •Patients who take drugs that can cause hepatic steatosis
- •Patient diagnosed with a malignant tumor within 5 years before screening or relapsed patient
- •Patients with uncontrolled diabetes mellitus (HbA1c > 9%) or using insulin
- •Patients who participate in other clinical trials or is supposed to do so during the study period
- •Pregnant or breast-feeding women or women who have plan to be pregnant.
- •Patients with a history of hypersensitivity to the test drug or the components of the test drug
- •Patients with moderate or severe renal impairment
- •Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- •History within the past one years or presence of drug abuse or alcoholism.
- •Patient has serious disease judged by investigator such as heart failure, renal failure, and pancreatitis
- •Patient has liver diseases except chronic hepatitis B (i.e. hematochromatosis, alcoholic liver disease, nonalcoholic fatty liver disease, alpha-1 antitrypsin deficiency etc.)
- •Patient has history of organ transplantation
- •Patient concerned about the decline in daily activity or not able to understand the objectives and methods due to the psychiatric problems
- •Patients who are considered to be unacceptable in this study under the opinion of the investigator.
研究组 & 干预措施
Besifovir dipivoxil+L-carnitine
Experimental
Besifovir dipivoxil 150 mg and L-carnitine 330 mg
干预措施: Besifovir dipivoxil (Drug)
Besifovir dipivoxil+L-carnitine
Experimental
Besifovir dipivoxil 150 mg and L-carnitine 330 mg
干预措施: L-carnitine (Drug)
Tenofovir Alafenamide
Active Comparator
Tenofovir Alafenamide 25mg
干预措施: Tenofovir Alafenamide (Drug)
结局指标
主要结局
The rate of subjects who showed HBV DNA undetected (less than 116 copies/mL (20 IU/mL)) at the 48 week
时间窗: at the 48th week
次要结局
- The rate of subjects who showed HBV DNA undetected (less than 116 copies/mL (20 IU/mL)) at the 24 week(at the 24th week)
研究者
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