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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04069858

Enrollment

Registered

2019-08-28

Start date

2016-12-01

Completion date

2020-12-31

Last updated

2020-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

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.

Interventions

DRUGSwitching to Generic Entecavir (Baracle®)

switching to Baracle® 1 mg (generic drug) in chronic hepatitis B patients taking Baraclude® 1 mg (brand drug)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention 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.

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Normalization of liver enzyme	12 months	ALT \< 40 IU/L
Loss of serological markers of hepatitis B e antigen	12 months	Loss of HBeAg
Signs of newly developing antiviral resistance	12 months	Elevation of hepatitis B virus DNA by 10 fold assessed by real time PCR

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026