Study on Three Types of Nucleotide/Nucleoside Analogues Treatment in Patients With Hepatitis b Virus Related Acute-on-chronic Liver Failure
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study is to investigate the clinical efficacy of three types of nucleotide/nucleoside analogues in treatment of HBV-related acute-on-chronic liver failure.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 65
Healthy Volunteers: f
View:
• Positive hepatitis b surface antigen or hepatitis b virus DNA \> 0.5 year;
• Age from 12 to 65 years old;
• Serum total bilirubin level \> 10 times upper limit of normal;
• Prothrombin time activity \< 40% or prothrombin time international ratio \> 1.5；
• Do not receive nucleotide/nucleoside analogues treatment in the past half year.
Locations
Other Locations
China
Third Affiliated Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Wenxiong Xu, Doctor
xwx1983@163.com
+8613760783281
Backup
Liang Peng, Doctor
pzp33@hotmail.com
+8613533978874
Time Frame
Start Date: 2019-02-21
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 150
Treatments
Active_comparator: ETV group
50 patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day from baseline to life-long.
Active_comparator: TDF group
50 patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to life-long.
Experimental: TAF group
50 patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day from baseline to life-long.
Related Therapeutic Areas
Sponsors
Leads: Third Affiliated Hospital, Sun Yat-Sen University