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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

NCT05282407 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2022-04-01

No results posted yet for this study

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

Interventions

DRUG

Tenofovir disoproxil 245mg

1 tablet q.d. for 48 weeks

DRUG

Tenofovir disoproxil fumarate 300mg

1 tablet q.d. for 48 weeks

Sponsors & Collaborators

  • Samjin Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yoon Jun Kim, Ph.D. · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-20
Primary Completion
2019-04-17
Completion
2019-04-17

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05282407 on ClinicalTrials.gov