Treatment for liver fibrosis caused by hepatitis B virus
A Multicentre Clinical Trial in HBsAg Seroclearance After Receiving Combined Therapy of Peginterferon and Tenofovir in Nucleos(t)Ide Analogue-treated Patients With HBV Related Liver Fibrosis.
This study is testing a new combination treatment for adults with liver fibrosis caused by hepatitis B to see if it can improve their liver health better than the usual medication.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 336 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Third Affiliated Hospital, Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04640129 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a combined therapy using pegylated-interferon-α and tenofovir disoproxil fumarate in adults with liver fibrosis related to hepatitis B virus infection. The study aims to achieve HBsAg seroclearance, which is associated with improved long-term prognosis. Participants will be monitored for liver function and fibrosis levels, and the trial will assess the potential benefits of this dual therapy compared to standard nucleos(t)ide analogue treatment alone.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 55 with positive hepatitis B surface antigen and liver fibrosis classified as F1 to F3.
Not a fit: Patients with decompensated cirrhosis, hepatocellular carcinoma, or other active liver diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve liver health and reduce the risk of cirrhosis and liver cancer in patients with hepatitis B-related liver fibrosis.
How similar studies have performed: Other studies have shown promising results with similar combined therapies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1.Positive hepatitis b surface antigen; 2.Infection of hepatitis b virus DNA \> 0.5 year before anti-HBV treatment; 3.Receiving treatment of nucleoside/nucleotide analogues at least one year before recruited; 4.Age from 18 to 55 years old; 5.Normal liver function(ALT\<ULN,AST\<ULN and TBil\<ULN); 6.Undetectable hepatitis b virus DNA or less than 100IU/ml; 7.Liver biopsy suggested fibrosis of liver into F1\~F3(Metavir score system) or LSM between 6 and 12 kpa measured by fibroscan; 8.Liver ultrasound: normal or echo thickening, and portal vein diameter ≤ 12mm. Exclusion Criteria: * 1.Decompensated cirrhosis, hepatocellular carcinoma or other malignancy; 2.Pregnancy, lactation or female has plan of pregnancy within 18 months; 3.Accompanied with other active liver diseases(HAV, HCV, HDV, HEV, autoimmune liver disease, drug-induced liver injury, alcoholic liver disease, genetic metabolic liver disease, etc.)； 4.Accompanied with human immunodeficiency virus infection or congenital immune deficiency diseases; 5.Accompanied with severe diabetes, autoimmune diseases etc. and other important organ dysfunctions; 6.Patients who fail to comply with this research arrangement and sign an informed consent form; 7.Patients can not follow-up; 8.Investigator considering inappropriate.
Where this trial is running
Guangzhou, Guangdong
- Third Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
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.