KCT0008032已完成未知
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
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •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
排除标准
- •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.)
研究者
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