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

Hepatitis B Virus Clinical Trial

— ALTHBV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04231565
• Other study ID #: PL10
• Status: Recruiting
• Phase: N/A
• Start date: June 4, 2020
• Est. completion date: July 1, 2027

Study information

• Verified date: February 2024
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Qiumin Luo, Doctor
• Phone: +8613632399075
• Email: lqiumin[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 1, 2027
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Virus

Intervention

Drug:
• Tenofovir alafenamide Fumarate
Patients would receive treatment of oral Tenofovir alafenamide Fumarate(TAF)once per day.

Locations

Country	Name	City	State
China	Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hepatitis b s antigen decrease from baseline	Magnitude of decrease in hepatitis B antigen quantification from baseline to week 144.	48 week, 96 week, 144 week
Secondary	hepatitis b e antigen loss rate	Hepatitis b e antigen would be tested to know the ratio of patients with negative hepatitis B e antigen.	48 week, 96 week, 144 week
Secondary	hepatitis b virus(HBV) DNA undetectable rate	Hepatitis b virus DNA would not be detected if it below the upper limit of test value	48 week, 96 week, 144 week
Secondary	hepatitis b virus(HBV) RNA undetectable rate	Hepatitis b virus RNA would not be detected if it below the upper limit of test value	48 week, 96 week, 144 week
Secondary	hepatitis b s antigen loss rate	Hepatitis b s antigen become negative and quantitative analysis below the upper limit of test value	48 week, 96 week, 144 week