Back to resultsClinical Trial to Evaluate the Efficacy and Safety of TenofoBell® Tablet in Chronic Hepatitis B Patients
Primary Purpose
Chronic Hepatitis B
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Experimental
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis B
Eligibility Criteria
1. Inclusion Criteria:
- Patients who show positive HBsAg
- Patients who show positive or negative HBeAg
2. Exclusion Criteria:
- Patients who have hepatitis C(HCV), hepatitis D(HDV) or human immunodeficiency virus(HIV)
- Patients with a history of allergic reaction to Tenofovir
- Patients who are unable to participate in clinical trials based on investigator's decision.
Sites / Locations
- Daegu Chatholic University Medical center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental group
Arm Description
Outcomes
Primary Outcome Measures
Rate of subjects with HBV DNA less than 20 IU/mL
Secondary Outcome Measures
Full Information
NCT ID
NCT04539652
First Posted
September 1, 2020
Last Updated
July 26, 2021
Sponsor
Chong Kun Dang Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT04539652
Brief Title
Clinical Trial to Evaluate the Efficacy and Safety of TenofoBell® Tablet in Chronic Hepatitis B Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
June 22, 2021 (Actual)
Study Completion Date
June 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Experimental
Intervention Description
Experimental group are treated with TenofoBell®
Primary Outcome Measure Information:
Title
Rate of subjects with HBV DNA less than 20 IU/mL
Time Frame
change after 48 weeks compared to baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
1. Inclusion Criteria:
Patients who show positive HBsAg
Patients who show positive or negative HBeAg
2. Exclusion Criteria:
Patients who have hepatitis C(HCV), hepatitis D(HDV) or human immunodeficiency virus(HIV)
Patients with a history of allergic reaction to Tenofovir
Patients who are unable to participate in clinical trials based on investigator's decision.
Facility Information:
Facility Name
Daegu Chatholic University Medical center
City
Daegu
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Trial to Evaluate the Efficacy and Safety of TenofoBell® Tablet in Chronic Hepatitis B Patients
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