Treatment of Hepatitis B Related Acute-On-Chronic Liver Failure with Nucleotide/Nucleoside Analogues
Study on Three Types of Nucleotide/Nucleoside Analogues Treatment in Patients With Hepatitis b Virus Related Acute-on-chronic Liver Failure
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 12 Years to 65 Years |
| Sex | All |
| Sponsor | Third Affiliated Hospital, Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT03920618 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with other active liver diseases, malignancies, or significant organ dysfunctions may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.