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
| Registry | NCT03604016 |
|---|---|
| Status | Unknown |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 76 (Estimated) |
| Sponsor | IlDong Pharmaceutical Co Ltd (Industry) |
| Conditions | Hepatitis B |
| Interventions | Besifovir dipivoxil, L-carnitine, Tenofovir Alafenamide (Drug) |
| Dates | start 2018-09-23 (estimated), primary completion 2020-07-30 (estimated), completion 2020-07-30 (estimated), first posted 2018-07-27, last updated 2018-08-23 |
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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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Besifovir dipivoxil+L-carnitine | Experimental | Drug: Besifovir dipivoxil; Drug: L-carnitine | Besifovir dipivoxil 150 mg and L-carnitine 330 mg |
| Tenofovir Alafenamide | Active comparator | Drug: Tenofovir Alafenamide | Tenofovir Alafenamide 25mg |
Sex: All, ages: 20 Years to any
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.