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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThird Affiliated Hospital, Sun Yat-Sen University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Tenofovir alafenamide Fumarate

    Drug

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: TAF groupActive comparator 1 intervention
Group B: Observation groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

hepatitis b s antigen decrease from baseline

Magnitude of decrease in hepatitis B antigen quantification from baseline to week 144.

Time frame
48 week, 96 week, 144 week

Secondary outcomes

1

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.

Time frame
48 week, 96 week, 144 week
2

hepatitis b virus(HBV) DNA undetectable rate

Hepatitis b virus DNA would not be detected if it below the upper limit of test value

Time frame
48 week, 96 week, 144 week
3

hepatitis b virus(HBV) RNA undetectable rate

Hepatitis b virus RNA would not be detected if it below the upper limit of test value

Time frame
48 week, 96 week, 144 week
4

hepatitis b s antigen loss rate

Hepatitis b s antigen become negative and quantitative analysis below the upper limit of test value

Time frame
48 week, 96 week, 144 week

Other outcomes

Sponsors and contacts

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