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

Phase 4

• Conditions: Chronic Hepatitis B
• Interventions: Drug: Switching to Generic Entecavir (Baracle®)

• Registration Number: NCT04069858
• Lead Sponsor: Korea University

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.

Study Timeline

• Study Start: 2016-12-01
• Primary Completion: 2019-03-01
• Study First Submitted: 2019-08-23
• Study First Submitted QC: 2019-08-24
• Study First Posted: 2019-08-28
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-12
• Last Update Posted: 2020-02-17
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Baracle	Switching to Generic Entecavir (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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Korea University Ansan Hospital; 🇰🇷 Ansan, Gyeonggi-do, Korea, Republic of