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

NCT04069858 | Unknown Phase 4 DMC

• 1 other identifier: 2106AS0033
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

• Non-detection rate of hepatitis B virus DNA

  undetectable HBV DNA (\<20 IU/mL) at 12 months after switching treatment.

  12 months

Secondary Outcomes (3)

• Normalization of liver enzyme

  12 months

• Loss of serological markers of hepatitis B e antigen

  12 months

• Signs of newly developing antiviral resistance

  12 months

Study Arms (1)

Baracle

EXPERIMENTAL

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

Drug: Switching to Generic Entecavir (Baracle®)

Interventions

Switching to Generic Entecavir (Baracle®) DRUG

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

Also known as: Antiviral therapy

Baracle

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Korea University: lead

Study Sites (1)

Korea University Ansan Hospital

Ansan, Gyeonggi-do, 15355, South Korea

Location

Related Publications (3)

• 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.

  PMID: 28427875 BACKGROUND

• 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.

  PMID: 29405329 BACKGROUND

• 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.

  PMID: 31185710 BACKGROUND

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hyung Joon Yim, MD

  Korea University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: August 28, 2019
• Study Start: December 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: December 31, 2020
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)