NCT03733652

Optimal Treatment for Poor Efficacy of Entecavir in Chronic Hepatitis B Patients

Study on the Optimal Treatment for Poor Efficacy of Entecavir in Chronic Hepatitis B Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

There are chronic hepatitis B patients with poor antiviral efficacy of entecavir in clinical practice. Tenofovir or interferon alfa is the optimal choice right now. The aim of this study is to investigate the therapeutic effect of using tenofovir of interferon alfa in these patients.

Detailed description

There are chronic hepatitis B patients with poor antiviral efficacy of entecavir in clinical practice. Poor efficacy is defined as hepatitis b virus DNA is still positive and decreases \> 2 lg from baseline. Sequential therapy by using tenofovir or interferon alfa is the optimal choice right now. 100 patients with poor antiviral efficacy of entecavir will be recruited in this study. They are randomly divided into tenofovir group or interferon alfa group. The aim of this study is to investigate the therapeutic effect of using tenofovir of interferon alfa in these patients.

Conditions

• Chronic Hepatitis b
• Efficacy, Self

Interventions

Type	Name	Description
DRUG	Interferon Alfa 2a	Patents are treated with interferon alfa 2a 180μg hypodermic injection once per week for 48 weeks. Then, interferon alfa 2a will be stopped if there is HBsAg clearance. Else, oral tenofovir 300mg once per day will be used if HBsAg is positive.

Timeline

• Start date: 2018-11-15
• Primary completion: 2021-09-30
• Completion: 2021-12-31
• First posted: 2018-11-07
• Last updated: 2018-11-23

Locations

1 site across 1 country: China