None listed
Conditions
Interventions
Drug : 1. Investigational Product: Besifovirdipivoxil 150mg, L-carnitine 330.0mg
2. Dose: Besifovirdipivoxil maleate 183 mg (Besifovirdipivoxil 150 mg), L-carnitine 330.0 mg
3. Number of times: Besifo
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women over 20 years of age and under 80 years of age 2. Patients who are patients with chronic hepatitis B and are subject to antiviral drug treatment according to the Korean Liver Association treatment guidelines (2018 Korean Liver Association hepatitis treatment guidelines) 3. Patients diagnosed with fatty liver (CAP value>250 dB/m) by Transient elastography 4. Among patients who meet the above conditions, the patient who signed the subject's consent form
Exclusion criteria
Exclusion criteria: 1. Patients who meet the criteria of alcoholic fatty liver (210g per week for men and 140g per week for women in the last two years) 2. Patients with liver diseases other than chronic hepatitis B (hemochromatosis, hepatocellular cancer, autoimmune liver disease, hepatitis C virus hepatitis, Wilson's disease) 3. Patients with liver cirrhosis with impaired liver function (CTP class B and C) 4. Those who take drugs that can cause fatty liver (thiazolidinedione, SGLT2i class, amiodarone, methotrexate, tamoxifen, valproate, corticosteroids, etc.) 5. If the drug or its components are allergic or overreacted to it 6. Patients with malnutrition, starvation, debilitating conditions (including severe infections, severe trauma before and after surgery), pituitary dysfunction or adrenal dysfunction 7. Patients who are receiving radiation and anti-cancer treatment for malignant tumors or have not received it for two years 8. Human immunodeficurity virus (HIV) infected person 9. Patients with severe infections, before and after surgery, and severe trauma 10. Patients who have undergone Gastrointestinal bypass 11. Heart failure (class ?~) during NYHA classification) or uncontrolled arrhythmia within 6 months *Table. New York Heart Association Classification Class I: The athletic ability is normal Class II: Daily exercise (walking fast or climbing a hill) causes breathing difficulties, heart palpitations, and chest pain. Class III: Symptoms appear with mild exercise (walking flat). Class IV: Symptoms also appear at rest. 12. Patients with acute cardiovascular disease within 12 weeks (with unstable angina, myocardial infarction, transient ischemic seizures, cerebrovascular disease, coronary bypass surgery, or coronary intervention history) 13. Patients with renal failure or chronic renal disease (estimated glomerular filtration rate <60 mL/min/1.73 m2) or dialysis 14. Anemia patients with an Hb level of less than 10.5 g/cm ??????? 15. Pregnant women, lactating women, and patients who are planning to conceive during this clinical trial or who have self-sustaining ability to disagree with contraception cannot use recognized contraception during the trial period (accredited contraception refers to hepatic wall contraception (condom), infertility surgery, oral contraceptives, etc.) 16. Patients who have taken clinical trial medicines from other clinical trials within 6 months of consent 17. Other persons who are unable to participate in clinical trials at the discretion of researchers 18. Those who cannot read the consent form (e.g., illiterate, foreigners, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the amount of fatty liver (CAP value) compared to baseline after 24 weeks of treatment with Besifovir/L-carnitine | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in liver fibrosis levels compared to baseline after 24 weeks of treatment for Besifovir/L-carnitine 2. Changes in AST/ALT compared to baseline after 24 weeks of treatment for Besifovir/L-carnitine 3. Normalization ratio of AST/ALT to baseline after 24 weeks of treatment for Besifovir/L-carnitine (<40IU/L) 4. Changes in HBV DNA compared to baseline after 24 weeks of treatment of Besifovir/L-carnitine 5. Non-detection ratio of HBV DNA to baseline after 24 weeks of treatment with Besifovir/L-carnitine (approximately 20 IU/ml) 6. Changes in total cholesterol compared to baseline after 24 weeks of treatment for Besifovir/L-carnitine 7. Changes in LDL-C compared to baseline after 24 weeks of treatment for Besifovir/L-carnitine 8. Changes in triglyceride compared to baseline after 24 weeks of treatment for Besifovir/L-carnitine 9. Changes in HDL-C compared to baseline after 24 weeks of treatment for Besifovir/L-carnitine 10. Changes in systolic and diastolic blood pressure compared to baseline after 24 weeks of treatment for Besifovir/L-carnitine 11. Changes in HbA1c levels compared to baseline after 24 weeks of treatment for Besifovir/L-carnitine (if subject with diabetes) 12. Evaluation of steatosis grade improvement through CAP value change compared to baseline after 24 weeks of treatment for Besifovir/L-carnitine 13. Evaluation of fibrosis grade improvement through liver diffness change compared to baseline after 24 weeks of treatment for Besifovir/L-carnitine | — |
Countries
Korea, Republic of
Contacts
Public ContactKim Seung Up
Yonsei University Health System, Severance Hospital
Outcome results
None listed