Switching From Tenofovir Disoproxil Fumarate to Besifovir Dipivoxil Maleate

NCT04202536 | Unknown Phase 4

• 1 other identifier: ID-BVCL-403
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

A research study to observe the safety, efficacy and tolerability of switching from Tenofovir Disoproxil Fumarate to Besifovir dipivoxil maleate in patients with chronic hepatitis B

Conditions

Hepatitis B; Besifovir Dipivoxil Maleate; Tenofovir Disoproxil Fumarate

Outcome Measures

Primary Outcomes (1)

• The rate of subjects who maintained hepatitis B virus (HBV) DNA less than 20 IU/mL at the 48th week

  at the 48th week

Secondary Outcomes (1)

• The rate of subjects who maintained HBV DNA less than 20 IU/mL at the 24th week

  at the 24th week

Study Arms (2)

TDF switch to Besifovir Dipivoxil Maleate

EXPERIMENTAL

Tenofovir Disoproxil Fumarate(TDF) 300mg daily switch to Besifovir Dipivoxil Maleate 183mg daily

Drug: Besifovir Dipivoxil Maleate

Maintaining on TDF

ACTIVE COMPARATOR

Maintaining on Tenofovir Disoproxil Fumarate(TDF) 300mg daily

Drug: Tenofovir disoproxil fumarate(TDF)

Interventions

Besifovir Dipivoxil Maleate DRUG

Besifovir 150 mg q.d. + L-carnitine (L-Carn Tab. 330 mg) 660 mg q.d. Other Name: Besifovir®

TDF switch to Besifovir Dipivoxil Maleate

Tenofovir disoproxil fumarate(TDF) DRUG

300 mg tablet administered orally once daily Other Name: VIREAD®

Maintaining on TDF

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
• Patients who show positive HBsAg or has a history of chronic hepatitis B for the last six months or more before screening
• Patients who have been on tenofovir disoproxil fumarate (TDF) monotherapy for more than 48 weeks and are taking TDF at the time of clinical screening
• At screening, had HBV DNA \< 20 IU/mL
• Patients who were explained about the purpose, methods and effects of the clinical trial and then, signed a written consent form

You may not qualify if:

• Patients who have received interferon (including Pegylation formulation) to treat chronic hepatitis for more than 12 months.
• Patients who have taken Besifovir
• Patients who have experienced hepatitis B virus resistance to antiviral drugs
• Patient diagnosed with a malignant tumor within 5 years before screening or relapsed patient
• Patient has history of organ transplantation
• Patients who had received the following drugs for the last two months before screening (however, short-term use (less than consecutive 14 days) of these drugs and low-dose aspirin (100 mg, maximally, 300 mg/day) are allowed.)
• Nephrotoxic drugs (e.g. Aminoglycosides, Amphotericin B, NSAIDs)
• Hepatotoxic drugs (e.g. Erythromycin, Ketoconazole, Rifampin, Fluconazole, Dapsone)
• Anticoagulant (e.g. Warfarin)
• Patients who are suspected by an investigator to have the level of immunity decreased among patients who had been administered with immunosuppressants within 12 months before screening
• Patients who had been administered with long-term general corticosteroids (more than consecutive 14 days) at a high dose (more than prednisolone 20 mg daily\*) within three months before screening (In case of local corticosteroids, an investigator decides it.)
• It is equal to cortisone 125 mg, hydrocortisone 100 mg, prednisone 20 mg, methylprednisolone 16 mg, triamcinolone 16 mg, dexamethasone 3 mg, betamethasone 2.4 mg
• Patients who have a past medical history of clinical alcohol or drug abuse within a year before screening or now are abusers
• Patients with hepatitis C virus, hepatitis D virus or human immunodeficiency virus
• Patients who have other hepatic diseases (hematochromatosis, Wilson's disease, alcoholic liver diseases, nonalcoholic steatohepatitis, α1-antitrypsin deficiency) except hepatitis B

Sponsors & Collaborators

• IlDong Pharmaceutical Co Ltd: lead

Study Sites (1)

Korea University Medical Center

Ansan, Kyounggi-do, South Korea

RECRUITING

MeSH Terms

Conditions

Hepatitis B

Interventions

Tenofovir

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)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Yoan Park

CONTACT

82-2-526-3524; yapark@ildong.com

Hyoju Pyo

CONTACT

82-2-526-3192; hyoju@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: December 16, 2019
• First Posted: December 17, 2019
• Study Start: May 29, 2019
• Primary Completion: June 1, 2021
• Study Completion: October 1, 2021
• Last Updated: December 17, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)