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

IlDong Pharmaceutical

Status and phase: Unknown; Phase 4

Conditions: Hepatitis B

Treatments: Drug: L-carnitine; Drug: Besifovir dipivoxil; Drug: Tenofovir Alafenamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT03604016

ID-BVCL-401

Details and patient eligibility

About

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

Enrollment: 76 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Besifovir dipivoxil+L-carnitine

Experimental group

Description:

Besifovir dipivoxil 150 mg and L-carnitine 330 mg

Treatment:

Drug: L-carnitine

Drug: Besifovir dipivoxil

Tenofovir Alafenamide

Active Comparator group

Description:

Tenofovir Alafenamide 25mg

Treatment:

Drug: Tenofovir Alafenamide