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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-04

Study Completion Date

2027-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatitis B Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Tenofovir alafenamide Fumarate

Intervention Type DRUG

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

Observation group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tenofovir alafenamide Fumarate

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

Intervention Type DRUG

Other Intervention Names

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Vemlidy

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No