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

K

Korea University

Status and phase

Unknown
Phase 4

Conditions

Chronic Hepatitis B

Treatments

Drug: Switching to Generic Entecavir (Baracle®)

Study type

Interventional

Funder types

Other

Identifiers

NCT04069858
2106AS0033

Details and patient eligibility

About

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

Full 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.

Enrollment

40 patients

Sex

All

Ages

19+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Baracle
Experimental group
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
Treatment:
Drug: Switching to Generic Entecavir (Baracle®)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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