Maintaining Antiviral Efficacy After Switching to Generic Entecavir 1 mg for Chronic Hepatitis B
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
Summary
- Conditions
- Chronic Hepatitis B
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention 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.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 19 years and 125 years
- Gender
- Both males and females
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 mon...
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.
Tracking Information
- NCT #
- NCT04069858
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Hyung Joon Yim, MD Korea University
Get Well Soon