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

Chong Kun Dang

Status and phase: Completed; Phase 4

Conditions: Chronic Hepatitis B

Treatments: Drug: Experimental

Study type: Interventional

Funder types: Industry

Identifiers

NCT04539652

285HBV18018

Details and patient eligibility

About

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

Enrollment: 78 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Inclusion Criteria:

2. Patients who show positive HBsAg

3. Patients who show positive or negative HBeAg

4. Exclusion Criteria:

5. Patients who have hepatitis C(HCV), hepatitis D(HDV) or human immunodeficiency virus(HIV)

6. Patients with a history of allergic reaction to Tenofovir

7. Patients who are unable to participate in clinical trials based on investigator's decision.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 1 patient group

Experimental group

Experimental group

Treatment:

Drug: Experimental