search
Back to results

Maintaining Antiviral Efficacy After Switching to Generic Entecavir 1 mg for Chronic Hepatitis B

Primary Purpose

Chronic Hepatitis B

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Switching to Generic Entecavir (Baracle®)
Sponsored by
Korea University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B

Eligibility Criteria

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

Inclusion Criteria:

  • Age >19 years old CHB patients
  • Confirmed antiviral resistance
  • Taking brand entecavir 1 mg for more than 1 year
  • HBV DNA < 20 IU/mL
  • Compensated liver cirrhosis
  • Willing to participate

Exclusion Criteria:

  • Failure to meet the inclusion criteria
  • Cr>1.5 mg/dL
  • Postive HCV Ab
  • Decompensated cirrhosis
  • Pregnant women
  • HCC
  • Alcoholics

Sites / Locations

  • Korea University Ansan Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Baracle

Arm Description

Chronic hepatitis B patients who swiched to Baracle® 1 mg from Baraclude® 1 mg treatment as mono- or combination therapy after the development of antiviral resistance to nucleos(t)ide analogues

Outcomes

Primary Outcome Measures

Non-detection rate of hepatitis B virus DNA
undetectable HBV DNA (<20 IU/mL) at 12 months after switching treatment.

Secondary Outcome Measures

Normalization of liver enzyme
ALT < 40 IU/L
Loss of serological markers of hepatitis B e antigen
Loss of HBeAg
Signs of newly developing antiviral resistance
Elevation of hepatitis B virus DNA by 10 fold assessed by real time PCR

Full Information

First Posted
August 23, 2019
Last Updated
February 12, 2020
Sponsor
Korea University
search

1. Study Identification

Unique Protocol Identification Number
NCT04069858
Brief Title
Maintaining Antiviral Efficacy After Switching to Generic Entecavir 1 mg for Chronic Hepatitis B
Official Title
Maintaining Antiviral Efficacy After Switching to Generic Entecavir, Baracle® in Patients Taking Baraclude® 1 mg for Antiviral Resistant Chronic Hepatitis B; A Noninferiority Study Assessing Non-detection Rate of Hepatitis B Virus DNA
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Entecavir 1 mg is commonly used in patients with chronic hepatitis B (CHB) patients with previous antiviral resistance. This study evaluates the efficacy and safety of switching to generic entecavir 1 mg (Baracle®, Dong-A Science Technology) in CHB patients taking brand name entecavir 1 mg (Baraclude®, Bristol-Myers Squibb) alone or in combination with other nucleos(t)ide analogues after the development of antiviral resistance. The primary aim is virological response (<20 IU/mL) at 12 months
Detailed Description
This study is a prospective single-arm open-label trial. The primary endpoint is virological response (<20 IU/mL) at 12 months after switching treatment. Patients who satisfy the inclusion and exclusion criteria will switch from Baraclude® 1 mg to Baracle®. Assessment of treatment response at 12 months is performed by comparing undetectable HBV DNA rates between baseline and 12 months after switching therapy.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
CHB patients receiving treatment with Baraclude® 1 mg alone or in combination with other nucleos(t)ide analogues for 12 months or longer after the development of antiviral resistance.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baracle
Arm Type
Experimental
Arm Description
Chronic hepatitis B patients who swiched to Baracle® 1 mg from Baraclude® 1 mg treatment as mono- or combination therapy after the development of antiviral resistance to nucleos(t)ide analogues
Intervention Type
Drug
Intervention Name(s)
Switching to Generic Entecavir (Baracle®)
Other Intervention Name(s)
Antiviral therapy
Intervention Description
switching to Baracle® 1 mg (generic drug) in chronic hepatitis B patients taking Baraclude® 1 mg (brand drug)
Primary Outcome Measure Information:
Title
Non-detection rate of hepatitis B virus DNA
Description
undetectable HBV DNA (<20 IU/mL) at 12 months after switching treatment.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Normalization of liver enzyme
Description
ALT < 40 IU/L
Time Frame
12 months
Title
Loss of serological markers of hepatitis B e antigen
Description
Loss of HBeAg
Time Frame
12 months
Title
Signs of newly developing antiviral resistance
Description
Elevation of hepatitis B virus DNA by 10 fold assessed by real time PCR
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >19 years old CHB patients Confirmed antiviral resistance Taking brand entecavir 1 mg for more than 1 year HBV DNA < 20 IU/mL Compensated liver cirrhosis Willing to participate Exclusion Criteria: Failure to meet the inclusion criteria Cr>1.5 mg/dL Postive HCV Ab Decompensated cirrhosis Pregnant women HCC Alcoholics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyung Joon Yim, MD
Organizational Affiliation
Korea University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Ansan Hospital
City
Ansan
State/Province
Gyeonggi-do
ZIP/Postal Code
15355
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28427875
Citation
European Association for the Study of the Liver. Electronic address: easloffice@easloffice.eu; European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2017 Aug;67(2):370-398. doi: 10.1016/j.jhep.2017.03.021. Epub 2017 Apr 18.
Results Reference
background
PubMed Identifier
29405329
Citation
Terrault NA, Lok ASF, McMahon BJ, Chang KM, Hwang JP, Jonas MM, Brown RS Jr, Bzowej NH, Wong JB. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018 Apr;67(4):1560-1599. doi: 10.1002/hep.29800. No abstract available.
Results Reference
background
PubMed Identifier
31185710
Citation
Korean Association for the Study of the Liver (KASL). KASL clinical practice guidelines for management of chronic hepatitis B. Clin Mol Hepatol. 2019 Jun;25(2):93-159. doi: 10.3350/cmh.2019.1002. Epub 2019 Jun 12. No abstract available.
Results Reference
background

Learn more about this trial

Maintaining Antiviral Efficacy After Switching to Generic Entecavir 1 mg for Chronic Hepatitis B

We'll reach out to this number within 24 hrs