Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Hepatitis B

Intervention / Treatment
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* Drug: Besifovir dipivoxil
* Drug: L-carnitine
* Drug: Tenofovir Alafenamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Besifovir dipivoxil+L-carnitine<br>Besifovir dipivoxil 150 mg and L-carnitine 330 mg | Drug: Besifovir dipivoxil<br>* Besifovir dipivoxil 150 mg<br>Drug: L-carnitine<br>* Besifovir dipivoxil 150 mg<br>|
| Active Comparator: Tenofovir Alafenamide<br>Tenofovir Alafenamide 25mg | Drug: Tenofovir Alafenamide<br>* Tenofovir Alafenamide 25mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of subjects who showed HBV DNA undetected (less than 116 copies/mL (20 IU/mL)) at the 48 week |  | at the 48th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |