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NCT04539652 Clinical Trial

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

Chronic Hepatitis B Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04539652
Other study ID # 285HBV18018
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 20, 2018
Est. completion date June 22, 2021

Study information
Verified date July 2021
Source Chong Kun Dang Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 78
Est. completion date June 22, 2021
Est. primary completion date June 22, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Experimental
Experimental group are treated with TenofoBell®

Locations
Country Name City State
Korea, Republic of Daegu Chatholic University Medical center Daegu

Sponsors (1)
Lead Sponsor Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of subjects with HBV DNA less than 20 IU/mL change after 48 weeks compared to baseline
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