Clinical trial Recruiting at 1 site Interventional Ages 12 to 65

Treatment of Hepatitis B Related Acute-On-Chronic Liver Failure with Nucleotide/Nucleoside Analogues

Official title: Study on Three Types of Nucleotide/Nucleoside Analogues Treatment in Patients With Hepatitis b Virus Related Acute-on-chronic Liver Failure

Run by Third Affiliated Hospital, Sun Yat-Sen University · NCT03920618 · Data updated 2026-11-12

This study is testing if three antiviral medications can help people with hepatitis B-related liver failure feel better and improve their chances of recovery.

More Hepatitis B trials

Quick facts

Study typeInterventional
Ages12 Years to 65 Years
SexAll
Enrollment150 (estimated)
SponsorThird Affiliated Hospital, Sun Yat-Sen University
Academic / other
Locations1 site (Guangzhou, Guangdong)
StatusRecruiting
StartedFebruary 21, 2019
Main results expectedDecember 31, 2024
Study endsDecember 31, 2024
Registry record updatedNovember 29, 2024
Trial IDNCT03920618 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are individuals aged 12 to 65 with positive hepatitis B surface antigen or HBV DNA and severe liver dysfunction.

Probably not a fit

Patients with other active liver diseases, malignancies, or significant organ dysfunctions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the clinical efficacy of three nucleotide/nucleoside analogues—Entecavir, Tenofovir Disoproxil Fumarate, and Tenofovir Alafenamide—in treating patients with hepatitis B virus-related acute-on-chronic liver failure (ACLF). Given the high mortality rate associated with ACLF in China, the study aims to provide valuable data on the effectiveness of these antiviral treatments, particularly focusing on Tenofovir Alafenamide, which has limited data in this context. Participants will be monitored for their response to the treatments over a specified period.

Why it matters

Potential benefit: If successful, this study could provide effective treatment options for patients suffering from HBV-related ACLF, potentially reducing mortality rates.

How similar studies have gone: While nucleotide/nucleoside analogues have been used in treating hepatitis B, the specific application of Tenofovir Alafenamide in ACLF is novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Positive hepatitis b surface antigen or hepatitis b virus DNA \> 0.5 year;
2. Age from 12 to 65 years old;
3. Serum total bilirubin level \> 10 times upper limit of normal;
4. Prothrombin time activity \< 40% or prothrombin time international ratio \> 1.5;
5. Do not receive nucleotide/nucleoside analogues treatment in the past half year.

Exclusion Criteria:

1. Other active liver diseases;
2. Hepatocellular carcinoma or other malignancy;
3. Pregnancy or lactation;
4. 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.

Where it's running

  • Third Affiliated Hospital of Sun Yat-sen University
    Guangzhou, Guangdong, China
    Recruiting

Study contacts

  • Principal investigator: Liang Peng, Doctor — Third Affiliated Hospital, Sun Yat-Sen University
  • Study coordinator: Wenxiong Xu, Doctor
  • Email: xwx1983@163.com
  • Phone: +8613760783281

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.