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

• Status: Unknown status
• Trial end date: 2020-07-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IlDong Pharmaceutical Co Ltd
• Treatments: Tenofovir

Criteria

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.