A clinical trial to evaluate the reduction of hepatic fat content and safety of Besifovir and L-carnitine solution for chronic hepatitis B patients and fatty liver: Multicenter, prospective, single group trial
- Conditions
- Diseases of the digestive system
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
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
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.)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in the amount of fatty liver (CAP value) compared to baseline after 24 weeks of treatment with Besifovir/L-carnitine
- Secondary Outcome Measures
Name Time Method