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

NCT ID: NCT04539652

Last Updated: 2021-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-20
• Study Completion Date: 2021-06-22

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

Conditions

Chronic Hepatitis B

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

Group Type: EXPERIMENTAL

Experimental

Intervention Type: DRUG

Experimental group are treated with TenofoBell®

Interventions

Experimental

Experimental group are treated with TenofoBell®

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients who show positive HBsAg

2. Patients who show positive or negative HBeAg

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Daegu Chatholic University Medical center

Daegu, , South Korea

Countries

South Korea

Other Identifiers

285HBV18018

Identifier Type: -

Identifier Source: org_study_id