NCT04539652

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2021

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

2.8 years

First QC Date

September 1, 2020

Last Update Submit

July 26, 2021

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

  • Rate of subjects with HBV DNA less than 20 IU/mL

    change after 48 weeks compared to baseline

Study Arms (1)

Experimental group

EXPERIMENTAL
Drug: Experimental

Interventions

ExperimentalDRUG

Experimental group are treated with TenofoBell®

Experimental group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who show positive HBsAg
  • Patients who show positive or negative HBeAg

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daegu Chatholic University Medical center

Daegu, South Korea

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2020

First Posted

September 7, 2020

Study Start

September 20, 2018

Primary Completion

June 22, 2021

Study Completion

June 22, 2021

Last Updated

July 28, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)