NCT05282407

A phase4 Clinical Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Disoproxil From Tenofovir Disoproxil Fumarate in Patients With Chronic Hepatitis B

A Multi-Center, Randomized, Open-label, Parallel, Active-controlled, Non-inferiority, Phase IV Clinical Trial to Evaluate the Safety and Efficacy of Switching to Tenolid Tab From Viread Tab in Chronic Hepatitis B Patients on Treatment With Tenofovir Disoproxil Fumarate

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Samjin Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase4, multicenter, open-label, randomized study to demonstrate that the Tenolid Tab switching group is non-inferior to the virologic suppression effect compared to the Viread Tab continuous administration group and evaluate the safety of Tenolid Tab. This clinical trial was conducted on patients who were taking Viread Tab as monotherapy for more than 48 weeks for chronic hepatitis B. At the time of screening(Visit 1), information on factors related to medical history and prognosis including Viread Tab administration were collected retrospectively from the subjects who voluntarily signed the informed consent form (ICF). Only subjects who are determined to be suitable for the study eligibility(inclusion/exclusion) criteria as a result of the screening evaluations are randomized in a 1:1 ratio to one of the two groups at the baseline. Subjects will receive investigational product start on the next day of randomization for 48 weeks. Subjects will visit to the study site on 12, 24, 36, 24 weeks after starting dosing investigational product and evaluated for effectiveness of virologic suppression and safety.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	Tenofovir disoproxil 245mg	1 tablet q.d. for 48 weeks
DRUG	Tenofovir disoproxil fumarate 300mg	1 tablet q.d. for 48 weeks

Timeline

• Start date: 2017-11-20
• Primary completion: 2019-04-17
• Completion: 2019-04-17
• First posted: 2022-03-16
• Last updated: 2022-04-01

Locations

1 site across 1 country: South Korea