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

Phase 4

Completed

• Conditions: Chronic Hepatitis B
• Interventions: Drug: Experimental

• Registration Number: NCT04539652
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-20
• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-01
• Study First Posted: 2020-09-07
• Primary Completion: 2021-06-22
• Study Completion: 2021-06-22
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

1. Patients who show positive HBsAg

2. Patients who show positive or negative HBeAg

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	Experimental	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Daegu Chatholic University Medical center; 🇰🇷 Daegu, Korea, Republic of