Study on Therapeutic Effects and Safety of Nucleoside (Acid) Analogues Treatment in Patients With Chronic Hepatitis B With Normal Alanine Aminotransferase and Positive Hepatitis B Virus DNA: a Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study is to investigate the clinical efficacy and safety of Nucleoside (acid) analogues treatment in patients with normal Alanine Aminotransferase and positive Hepatitis B virus DNA.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Positive hepatitis b surface antigen and hepatitis b antibody \> 0.5 year;
• Age from 18 to 65 years old;
• Serum Alanine Aminotransferase(ALT) ≤1×ULN at least 12 weeks;
• Positive Hepatitis b virus(HBV);
• Do not receive nucleotide/nucleoside analogues or interferon treatment in the past half year.
Locations
Other Locations
China
Third Affiliated Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Qiumin Luo, Doctor
lqiumin@126.com
+8613632399075
Backup
Liang Peng, Doctor
pzp33@hotmail.com
+8613533978874
Time Frame
Start Date: 2020-06-04
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 200
Treatments
Active_comparator: TAF group
100 patients would receive treatment of oral Tenofovir alafenamide Fumarate(TAF) 25 mg once per day from baseline to life-long unless the patient achieves HBsAg loss.
No_intervention: Observation group
100 patients would not receive treatment from baseline to life-long.
Related Therapeutic Areas
Sponsors
Leads: Third Affiliated Hospital, Sun Yat-Sen University