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

NCT03604016 | Unknown Phase 4

• 1 other identifier: ID-BVCL-401
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

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

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• 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 (1)

• The change of liver fat at 48 weeks

  at the 48th weeks

Study Arms (2)

Besifovir dipivoxil+L-carnitine

EXPERIMENTAL

Besifovir dipivoxil 150 mg and L-carnitine 330 mg

Drug: Besifovir dipivoxil; Drug: L-carnitine

Tenofovir Alafenamide

ACTIVE COMPARATOR

Tenofovir Alafenamide 25mg

Drug: Tenofovir Alafenamide

Interventions

Besifovir dipivoxil DRUG

Besifovir dipivoxil 150 mg

Besifovir dipivoxil+L-carnitine

L-carnitine DRUG

Besifovir dipivoxil 150 mg

Besifovir dipivoxil+L-carnitine

Tenofovir Alafenamide DRUG

Tenofovir Alafenamide 25mg

Tenofovir Alafenamide

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IlDong Pharmaceutical Co Ltd: lead

MeSH Terms

Conditions

Hepatitis B

Interventions

Carnitine; tenofovir alafenamide

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Central Study Contacts

Minju Hong

CONTACT

82105263644; mjhong@ildong.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: July 27, 2018
• Study Start: September 23, 2018
• Primary Completion: July 30, 2020
• Study Completion: July 30, 2020
• Last Updated: August 23, 2018

Record last verified: 2018-06