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NCT Number: NCT04231565

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

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location status: Recruiting

Location contact

Liang Peng, Doctor

CONTACT

[email protected]

+8613533978874

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tenofovir alafenamide fumarate

Drug

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

Other names: Vemlidy

Primary outcomes

  1. hepatitis b s antigen decrease from baseline

    Time frame: 48 week, 96 week, 144 week

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

Secondary outcomes

  1. hepatitis b e antigen loss rate

    Time frame: 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.

  2. hepatitis b virus(HBV) DNA undetectable rate

    Time frame: 48 week, 96 week, 144 week

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

  3. hepatitis b virus(HBV) RNA undetectable rate

    Time frame: 48 week, 96 week, 144 week

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

  4. hepatitis b s antigen loss rate

    Time frame: 48 week, 96 week, 144 week

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

Study contacts

Contact information is provided by the study sponsor or research team.

Liang Peng, Doctor

CONTACT

[email protected]

+8613533978874

Qiumin Luo, Doctor

CONTACT

[email protected]

+8613632399075

Sponsors and collaborators

Lead sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study 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

Acronym: ALTHBV

Important dates

Study start
2020
Primary completion
2024
Study completion
2027
First posted
Jan 18, 2020
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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