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

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

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

Study Overview

• Status: Unknown
• Conditions: Hepatitis B
• Intervention / Treatment: Drug: Besifovir dipivoxil; Drug: L-carnitine; Drug: Tenofovir Alafenamide

• Study Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Minju Hong; Phone Number: 82105263644; Email: mjhong@ildong.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Time Frame
The change of liver fat at 48 weeks	at the 48th weeks

Collaborators and Investigators

• Sponsor: IlDong Pharmaceutical Co Ltd

Study record dates

Study Major Dates

• Study Start (Anticipated): September 23, 2018
• Primary Completion (Anticipated): July 30, 2020
• Study Completion (Anticipated): July 30, 2020

Study Registration Dates

• First Submitted: July 19, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): August 23, 2018
• Last Update Submitted That Met QC Criteria: August 21, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis B; Hepatitis; Hepatitis A; Fatty Liver; Hepatitis B, Chronic; Non-alcoholic Fatty Liver Disease; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir
• Other Study ID Numbers: ID-BVCL-401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No