NCT04196998

Three Types of Nucleotide/Nucleoside Analogues Therapy in Patients With Hepatitis b Virus Related Compensated Cirrhosis

Study on Therapeutic Effects and Safety of Three Types of Nucleotide/Nucleoside Analogues in Patients With Hepatitis b Virus Related Compensated Cirrhosis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of hepatitis b virus related compensated cirrhosis.

Detailed description

Hepatitis b virus infection remains a serious public health problem in China. Nucleotide/nucleoside analogues are used for anti-virus treatment in these patients. Entecavir, Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide are first line drug in China. But there still lacks of data of Tenofovir Alafenamide in treatment of hepatitis b virus related compensated cirrhosis. This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of hepatitis b virus related compensated cirrhosis.

Conditions

• Hepatitis B
• Compensated Cirrhosis

Interventions

Type	Name	Description
DRUG	Entecavir	Patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day.
DRUG	Tenofovir Disoproxil Fumarate	Patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day.
DRUG	Tenofovir alafenamide	Patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day.

Timeline

• Start date: 2019-01-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2019-12-12
• Last updated: 2019-12-12

Locations

1 site across 1 country: China