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

Phase 4

• Conditions: Hepatitis B
• Interventions: Drug: Tenofovir Alafenamide; Drug: Besifovir dipivoxil; Drug: L-carnitine

• Registration Number: NCT03604016
• Lead Sponsor: IlDong Pharmaceutical Co Ltd

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-06
• Study First Submitted: 2018-07-19
• Study First Submitted QC: 2018-07-19
• Study First Posted: 2018-07-27
• Last Update Submitted: 2018-08-21
• Last Update Posted: 2018-08-23
• Study Start: 2018-09-23
• Primary Completion: 2020-07-30
• Study Completion: 2020-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Besifovir dipivoxil+L-carnitine	L-carnitine	Besifovir dipivoxil 150 mg and L-carnitine 330 mg
Tenofovir Alafenamide	Tenofovir Alafenamide	Tenofovir Alafenamide 25mg
Besifovir dipivoxil+L-carnitine	Besifovir dipivoxil	Besifovir dipivoxil 150 mg and L-carnitine 330 mg

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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