Clinical Trial to Evaluate the Efficacy and Safety of TenofoBell® Tablet in Chronic Hepatitis B Patients

A Multicenter, Single-Arm, Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of TenofoBell® Tablet in Chronic Hepatitis B Patients in Treatment of Oral Antiviral Therapy for Hepatitis B Virus

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04539652

Enrollment

Registered

2020-09-07

Start date

2018-09-20

Completion date

2021-06-22

Last updated

2021-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Brief summary

This study was designed to evaluate the rate of subjects with HBV DNA less than 20 IU/mL after taking TenofoBell® tablet for 48 weeks

Interventions

DRUGExperimental

Experimental group are treated with TenofoBell®

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

1\. Inclusion Criteria: 1. Patients who show positive HBsAg 2. Patients who show positive or negative HBeAg 2\.

Exclusion criteria

1. Patients who have hepatitis C(HCV), hepatitis D(HDV) or human immunodeficiency virus(HIV) 2. Patients with a history of allergic reaction to Tenofovir 3. Patients who are unable to participate in clinical trials based on investigator's decision.

Design outcomes

Primary

Measure	Time frame
Rate of subjects with HBV DNA less than 20 IU/mL	change after 48 weeks compared to baseline

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026