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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 12 Years to 65 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Third Affiliated Hospital, Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | February 21, 2019 |
| Main results expected | December 31, 2024 |
| Study ends | December 31, 2024 |
| Registry record updated | November 29, 2024 |
| Trial ID | NCT03920618 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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This study looks at the long-term health and recovery of people who have survived liver failure caused by hepatitis B to see how they are doing over time.
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This project will look back at people with hepatitis B–related ACLF who received MSC infusions to see which factors affect whether the treatment helps.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.