NCT02523547

Study to Evaluate the Non-inferiority of Cavir in HBeAg(+)Chronic Hepatitis B Patients Treated With Baraclude

PhaseIVstudy to Evaluate the Non-inferiority of Cavir®Tab. in Terms of Hepatitis B Virus(HBV)DNA Undetectability Comparing Baraclude® Tab. in Hepatitis B e Antigen(HBeAg)(+) Chronic Hepatitis B Patients Treated With Long-term Baraclude® Tab

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Open-labeled, Prospective, Randomized, Multi-center, Interventional, Phase IV study.

Detailed description

The purpose of this study is to evaluate the non-inferiority and safety in terms of HBV DNA undetectability comparing Baraclude Tab. in HBeAg(+) chronic hepatitis B patients treated with long-term Baraclude Tab.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	Cavir	0.5mg/day
DRUG	Baraclude	0.5mg/day

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2015-08-14
• Last updated: 2015-08-14

Locations

1 site across 1 country: South Korea