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

Sponsor

IlDong Pharmaceutical Co Ltd (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03604016

Collaborator

(none)

Enrollment

Arms

22.2

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B	Drug: Besifovir dipivoxil Drug: L-carnitine Drug: Tenofovir Alafenamide	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 23, 2018

Anticipated Primary Completion Date :

Jul 30, 2020

Anticipated Study Completion Date :

Jul 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Besifovir dipivoxil+L-carnitine Besifovir dipivoxil 150 mg and L-carnitine 330 mg	Drug: Besifovir dipivoxil Besifovir dipivoxil 150 mg Drug: L-carnitine Besifovir dipivoxil 150 mg
Active Comparator: Tenofovir Alafenamide Tenofovir Alafenamide 25mg	Drug: Tenofovir Alafenamide Tenofovir Alafenamide 25mg

Arm

Intervention/Treatment

Experimental: Besifovir dipivoxil+L-carnitine

Besifovir dipivoxil 150 mg and L-carnitine 330 mg

Drug: Besifovir dipivoxil

Besifovir dipivoxil 150 mg

Drug: L-carnitine

Besifovir dipivoxil 150 mg

Active Comparator: Tenofovir Alafenamide

Tenofovir Alafenamide 25mg

Drug: Tenofovir Alafenamide

Tenofovir Alafenamide 25mg

Outcome Measures

Primary Outcome Measures

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

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]

Other Outcome Measures

The change of liver fat at 48 weeks [at the 48th weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.