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NCT04069858 Clinical Trial

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

Chronic Hepatitis B Clinical Trial

Official title:
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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04069858
Other study ID # 2106AS0033
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date December 1, 2016
Est. completion date December 31, 2020

Study information
Verified date February 2020
Source Korea University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 40
Est. completion date December 31, 2020
Est. primary completion date March 1, 2019
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Switching to Generic Entecavir (Baracle®)
switching to Baracle® 1 mg (generic drug) in chronic hepatitis B patients taking Baraclude® 1 mg (brand drug)

Locations
Country Name City State
Korea, Republic of Korea University Ansan Hospital Ansan Gyeonggi-do

Sponsors (1)
Lead Sponsor Collaborator
Korea University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

European Association for the Study of the Liver. Electronic address: easloffice@easloffice.eu; 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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Non-detection rate of hepatitis B virus DNA undetectable HBV DNA (<20 IU/mL) at 12 months after switching treatment. 12 months
Secondary Normalization of liver enzyme ALT < 40 IU/L 12 months
Secondary Loss of serological markers of hepatitis B e antigen Loss of HBeAg 12 months
Secondary Signs of newly developing antiviral resistance Elevation of hepatitis B virus DNA by 10 fold assessed by real time PCR 12 months
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