Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver
NCT ID: NCT03604016
Last Updated: 2018-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
76 participants
INTERVENTIONAL
2018-09-23
2020-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Besifovir dipivoxil+L-carnitine
Besifovir dipivoxil 150 mg and L-carnitine 330 mg
Besifovir dipivoxil
Besifovir dipivoxil 150 mg
L-carnitine
Besifovir dipivoxil 150 mg
Tenofovir Alafenamide
Tenofovir Alafenamide 25mg
Tenofovir Alafenamide
Tenofovir Alafenamide 25mg
Interventions
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Besifovir dipivoxil
Besifovir dipivoxil 150 mg
L-carnitine
Besifovir dipivoxil 150 mg
Tenofovir Alafenamide
Tenofovir Alafenamide 25mg
Eligibility Criteria
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Inclusion Criteria
* 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 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.
20 Years
ALL
No
Sponsors
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IlDong Pharmaceutical Co Ltd
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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ID-BVCL-401
Identifier Type: -
Identifier Source: org_study_id
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