Clinical trial NCT04069858: Maintaining Antiviral Efficacy After Switching to Generic Entecavir 1 mg for Chronic Hepatitis B
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Hepatitis B
Lead sponsor: Korea University
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Non-detection rate of hepatitis B virus DNA
timeFrame: 12 months
Secondary outcomes:
measure: Normalization of liver enzyme
timeFrame: 12 months
measure: Loss of serological markers of hepatitis B e antigen
timeFrame: 12 months
measure: Signs of newly developing antiviral resistance
timeFrame: 12 months
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Gyeonggi-do
Study officials:
affiliation: Korea University
name: Hyung Joon Yim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. No abstract available.
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. No abstract available.