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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2020-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Chronic Hepatitis B

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Baracle

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

Group Type EXPERIMENTAL

Switching to Generic Entecavir (Baracle®)

Intervention Type DRUG

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

Interventions

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Switching to Generic Entecavir (Baracle®)

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

Intervention Type DRUG

Other Intervention Names

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Antiviral therapy

Eligibility Criteria

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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

* Cr\>1.5 mg/dL
* Postive HCV Ab
* Decompensated cirrhosis
* Pregnant women
* HCC
* Alcoholics

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No