Hepatitis B
Conditions
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
Interventions
DRUGTenofovir Alafenamide
Tenofovir Alafenamide 25mg
Besifovir dipivoxil 150 mg
DRUGL-carnitine
Besifovir dipivoxil 150 mg
Sponsors
IlDong Pharmaceutical Co Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| 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
| Measure | Time frame |
|---|---|
| The change of liver fat at 48 weeks | at the 48th weeks |
Contacts
Primary ContactMinju Hong
Outcome results
None listed