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

NCT03604016 — Phase 4, Unknown, 76 participants, IlDong Pharmaceutical Co Ltd

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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

RegistryNCT03604016
StatusUnknown
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment76 (Estimated)
SponsorIlDong Pharmaceutical Co Ltd (Industry)
ConditionsHepatitis B
InterventionsBesifovir dipivoxil, L-carnitine, Tenofovir Alafenamide (Drug)
Datesstart 2018-09-23 (estimated), primary completion 2020-07-30 (estimated), completion 2020-07-30 (estimated), first posted 2018-07-27, last updated 2018-08-23

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-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

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+Arms and interventions

ArmTypeInterventionsDescription
Besifovir dipivoxil+L-carnitineExperimentalDrug: Besifovir dipivoxil; Drug: L-carnitineBesifovir dipivoxil 150 mg and L-carnitine 330 mg
Tenofovir AlafenamideActive comparatorDrug: Tenofovir AlafenamideTenofovir Alafenamide 25mg
  • Besifovir dipivoxil (Drug): Besifovir dipivoxil 150 mg
  • L-carnitine (Drug): Besifovir dipivoxil 150 mg
  • Tenofovir Alafenamide (Drug): Tenofovir Alafenamide 25mg

+Outcome measures

Primary outcomes

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

Secondary outcomes

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

Other outcomes

  • The change of liver fat at 48 weeks [at the 48th weeks]

+Eligibility

Sex: All, ages: 20 Years to any

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.

My Notes