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Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver

Primary Purpose

Hepatitis B

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Besifovir dipivoxil
L-carnitine
Tenofovir Alafenamide
Sponsored by
IlDong Pharmaceutical Co Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Besifovir dipivoxil+L-carnitine

    Tenofovir Alafenamide

    Arm Description

    Besifovir dipivoxil 150 mg and L-carnitine 330 mg

    Tenofovir Alafenamide 25mg

    Outcomes

    Primary Outcome Measures

    The rate of subjects who showed HBV DNA undetected (less than 116 copies/mL (20 IU/mL)) at the 48 week

    Secondary Outcome Measures

    The rate of subjects who showed HBV DNA undetected (less than 116 copies/mL (20 IU/mL)) at the 24 week

    Full Information

    First Posted
    July 19, 2018
    Last Updated
    August 21, 2018
    Sponsor
    IlDong Pharmaceutical Co Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03604016
    Brief Title
    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

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 23, 2018 (Anticipated)
    Primary Completion Date
    July 30, 2020 (Anticipated)
    Study Completion Date
    July 30, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    IlDong Pharmaceutical Co Ltd

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis B

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    76 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Besifovir dipivoxil+L-carnitine
    Arm Type
    Experimental
    Arm Description
    Besifovir dipivoxil 150 mg and L-carnitine 330 mg
    Arm Title
    Tenofovir Alafenamide
    Arm Type
    Active Comparator
    Arm Description
    Tenofovir Alafenamide 25mg
    Intervention Type
    Drug
    Intervention Name(s)
    Besifovir dipivoxil
    Intervention Description
    Besifovir dipivoxil 150 mg
    Intervention Type
    Drug
    Intervention Name(s)
    L-carnitine
    Intervention Description
    Besifovir dipivoxil 150 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Tenofovir Alafenamide
    Intervention Description
    Tenofovir Alafenamide 25mg
    Primary Outcome Measure Information:
    Title
    The rate of subjects who showed HBV DNA undetected (less than 116 copies/mL (20 IU/mL)) at the 48 week
    Time Frame
    at the 48th week
    Secondary Outcome Measure Information:
    Title
    The rate of subjects who showed HBV DNA undetected (less than 116 copies/mL (20 IU/mL)) at the 24 week
    Time Frame
    at the 24th week
    Other Pre-specified Outcome Measures:
    Title
    The change of liver fat at 48 weeks
    Time Frame
    at the 48th weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Minju Hong
    Phone
    82105263644
    Email
    mjhong@ildong.com

    12. IPD Sharing Statement

    Learn more about this trial

    Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver

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