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The Efficacy and Safety of Switching to Vemliver Tab From Entecavir in Chronic Hepatitis B Patients Who Pretreated With Entecavir

Primary Purpose

Hepatitis B, Chronic

Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Vemliver tablet
Entecavir Tablet
Sponsored by
Daewoong Pharmaceutical Co. LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants aged 19 years and older as of the date of written consent. Individuals with a positive HBsAg for at least 24 weeks prior to screening or a history of chronic hepatitis B. Individuals with chronic hepatitis B who have been receiving ETV 0.5 mg as monotherapy for at least 24 weeks and have expressed the intention to switch to Barakros tablets or Bemeliver tablets. Participants with good adherence to ETV 0.5 mg monotherapy confirmed through questionnaire (≥80%). Participants who have demonstrated viral suppression efficacy (HBV DNA <69 IU/mL) and are deemed to require monotherapy with Tenofovir alafenamide or ETV for at least 48 weeks. Individuals who voluntarily agree to participate in the clinical trial and have signed the informed consent form. Exclusion Criteria: Medical history or surgical (treatment) history at the time of screening visit: ① Individuals diagnosed with substance abuse or alcohol addiction within the past year of screening. Confirmed diagnosis of malignant tumors, including liver cancer, within the past 5 years. Organ or bone marrow transplant recipients. Coexisting conditions at the time of screening visit: ① Non-selective clinical signs/symptoms in non-selective liver disease. Galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. Kidney disease patients requiring hemodialysis or peritoneal dialysis. ④ Other clinically significant cardiovascular, respiratory, neurological, or psychiatric conditions considered inappropriate for participation in the clinical trial according to the participant's judgment. Laboratory test results at the time of screening visit: ① Co-infection with HCV and HIV. Hemoglobin <8 g/dL. Impaired renal function. ④ ALT >3 × ULN. Anticipated use of the following drugs during the specified period: During the clinical trial period: Immunosuppressants. Systemic corticosteroids administered at a dose equal to or greater than a restricted dose for more than 2 weeks. Drugs affecting renal excretion, drugs with renal or hepatic toxicity. ④ Anti-HBV drugs other than investigational medicinal products. ⑤ Hepatotonics.

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment group

Comparator group

Arm Description

Chronic Hepatitis B patients who pretreated with Entecavir

Chronic Hepatitis B patients who pretreated with Entecavir

Outcomes

Primary Outcome Measures

HBV viral suppression rate
HBV viral suppression rate

Secondary Outcome Measures

Full Information

First Posted
July 16, 2023
Last Updated
August 17, 2023
Sponsor
Daewoong Pharmaceutical Co. LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT06000657
Brief Title
The Efficacy and Safety of Switching to Vemliver Tab From Entecavir in Chronic Hepatitis B Patients Who Pretreated With Entecavir
Official Title
The Efficacy and Safety of Switching to Vemliver Tab (Tenofovir Alafenamide Hemitartrate) From Entecavir in Chronic Hepatitis B Patients Who Pretreated With Entecavir; A Multi-Center, Randomized, Open-Label, Active-Controlled, Non-Inferiority, Phase IV Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2023 (Actual)
Primary Completion Date
July 29, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.

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
Enroll patients who are pre-treated with Entecavir at least 24 weeks and confirmed HBV antiviral (HBV DNA <69 IU/mL) effects. Subjects are given one test drug or comparator once a day for 48 weeks according to the results of random assignments, and their HBV antiviral inhibitory effect and safety are evaluated at 24 and 48 weeks visits.
Detailed Description
Enroll patients who are pre-treated with Entecavir at least 24 weeks and confirmed HBV antiviral (HBV DNA <69 IU/mL) effects. At the time of screening, potential test subjects of this test are selected by retrospectively collecting information on disease status and prognosis-related factors, including ETV administration information, among those who voluntarily agreed to participate in this clinical trial. HBeAg status (positive vs. positive) through Visit 1's Heptatis B Serology test before administering clinical trial drugs to test subjects who finally qualify for selection/exclusion criteria at the baseline. Voice) is set as a stratification factor and is randomly assigned to each test institution. Subjects are given one test drug or comparator once a day for 48 weeks according to the results of random assignments, and their HBV antiviral inhibitory effect and safety are evaluated at 24 and 48 weeks visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
196 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Chronic Hepatitis B patients who pretreated with Entecavir
Arm Title
Comparator group
Arm Type
Active Comparator
Arm Description
Chronic Hepatitis B patients who pretreated with Entecavir
Intervention Type
Drug
Intervention Name(s)
Vemliver tablet
Intervention Description
Chronic Hepatitis B Patients Who Pretreated with Entecavir switching to Vemliver tab (Tenofovir Alafenamide Hemitartrate)
Intervention Type
Drug
Intervention Name(s)
Entecavir Tablet
Intervention Description
Chronic Hepatitis B Patients Who Pretreated with Entecavir continuting treatement with Entecavir
Primary Outcome Measure Information:
Title
HBV viral suppression rate
Description
HBV viral suppression rate
Time Frame
at 48 weeks post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants aged 19 years and older as of the date of written consent. Individuals with a positive HBsAg for at least 24 weeks prior to screening or a history of chronic hepatitis B. Individuals with chronic hepatitis B who have been receiving ETV 0.5 mg as monotherapy for at least 24 weeks and have expressed the intention to switch to Barakros tablets or Bemeliver tablets. Participants with good adherence to ETV 0.5 mg monotherapy confirmed through questionnaire (≥80%). Participants who have demonstrated viral suppression efficacy (HBV DNA <69 IU/mL) and are deemed to require monotherapy with Tenofovir alafenamide or ETV for at least 48 weeks. Individuals who voluntarily agree to participate in the clinical trial and have signed the informed consent form. Exclusion Criteria: Medical history or surgical (treatment) history at the time of screening visit: ① Individuals diagnosed with substance abuse or alcohol addiction within the past year of screening. Confirmed diagnosis of malignant tumors, including liver cancer, within the past 5 years. Organ or bone marrow transplant recipients. Coexisting conditions at the time of screening visit: ① Non-selective clinical signs/symptoms in non-selective liver disease. Galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. Kidney disease patients requiring hemodialysis or peritoneal dialysis. ④ Other clinically significant cardiovascular, respiratory, neurological, or psychiatric conditions considered inappropriate for participation in the clinical trial according to the participant's judgment. Laboratory test results at the time of screening visit: ① Co-infection with HCV and HIV. Hemoglobin <8 g/dL. Impaired renal function. ④ ALT >3 × ULN. Anticipated use of the following drugs during the specified period: During the clinical trial period: Immunosuppressants. Systemic corticosteroids administered at a dose equal to or greater than a restricted dose for more than 2 weeks. Drugs affecting renal excretion, drugs with renal or hepatic toxicity. ④ Anti-HBV drugs other than investigational medicinal products. ⑤ Hepatotonics.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kim HeeJin
Phone
+8210-9911-1728
Email
hjkim221@daewoong.co.kr
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yunjun kim

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Not yet decided

Learn more about this trial

The Efficacy and Safety of Switching to Vemliver Tab From Entecavir in Chronic Hepatitis B Patients Who Pretreated With Entecavir

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