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

Sun Yat-sen University

Status: Enrolling

Conditions: Hepatitis B Virus

Treatments: Drug: Tenofovir alafenamide Fumarate

Study type: Interventional

Funder types: Other

Identifiers

NCT04231565

PL10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

TAF group

Active Comparator group

Description:

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.

Treatment:

Drug: Tenofovir alafenamide Fumarate

Observation group

No Intervention group

Description:

100 patients would not receive treatment from baseline to life-long.