Clinical trial NCT03604016: Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis B
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2018-07-27
Enrollment: 76
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: The rate of subjects who showed HBV DNA undetected (less than 116 copies/mL (20 IU/mL)) at the 48 week
timeFrame: at the 48th week
Secondary outcomes:
measure: The rate of subjects who showed HBV DNA undetected (less than 116 copies/mL (20 IU/mL)) at the 24 week
timeFrame: at the 24th week
Other outcomes:
measure: The change of liver fat at 48 weeks
timeFrame: at the 48th weeks
Locations:
Study officials:
References: