Nucleoside (Acid) Analogues Treatment in Patients With Normal ALT and Positive HBVDNA.

Not Applicable

Recruiting

• Conditions: Hepatitis B Virus
• Interventions: Drug: Tenofovir alafenamide Fumarate

• Registration Number: NCT04231565
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Brief 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.

Detailed Description

Hepatitis b virus infection has always been a global public health problem that endangers national health. Current clinical guidelines do not recommend antiviral therapy for people with positive hepatitis b-DNA and normal Alanine Aminotransferase, but studies have found that viral replication is associated with an increased risk of cirrhosis and liver tumors. Nucleoside (acid) analogues can effectively inhibit viral reverse transcriptase, reduce HBV viral load in the blood, thereby reducing secondary inflammation, and contribute to liver cell regeneration and disease recovery. And its side effect is small, adverse reaction rate is low, use safety.

Study Timeline

• Study First Submitted: 2020-01-13
• Study First Submitted QC: 2020-01-15
• Study First Posted: 2020-01-18
• Study Start: 2020-06-04
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-03-01
• Primary Completion: 2024-06-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 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.

Exclusion Criteria

• Other active liver diseases;
• Hepatocellular carcinoma or other malignancy;
• Pregnancy or lactation;
• Human immunodeficiency virus infection or congenital immune deficiency diseases; 5.Severe diabetes, autoimmune diseases; 6.Other important organ dysfunctions; 7.Using glucocorticoid; 8.Patients can not follow-up; 9.Investigator considering inappropriate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAF group	Tenofovir alafenamide Fumarate	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.

Primary Outcome Measures

Name	Time	Method
hepatitis b s antigen decrease from baseline	48 week, 96 week, 144 week	Magnitude of decrease in hepatitis B antigen quantification from baseline to week 144.

Secondary Outcome Measures

Name	Time	Method
hepatitis b virus(HBV) DNA undetectable rate	48 week, 96 week, 144 week	Hepatitis b virus DNA would not be detected if it below the upper limit of test value
hepatitis b virus(HBV) RNA undetectable rate	48 week, 96 week, 144 week	Hepatitis b virus RNA would not be detected if it below the upper limit of test value
hepatitis b s antigen loss rate	48 week, 96 week, 144 week	Hepatitis b s antigen become negative and quantitative analysis below the upper limit of test value
hepatitis b e antigen loss rate	48 week, 96 week, 144 week	Hepatitis b e antigen would be tested to know the ratio of patients with negative hepatitis B e antigen.

Trial Locations

Locations (1)

Third Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China