Treatment for Hepatitis B with Nucleoside Analogues
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
NA · Third Affiliated Hospital, Sun Yat-Sen University · NCT04231565
This study is testing if a new medication can help people with Hepatitis B who have normal liver enzyme levels and active virus to lower the virus in their body and protect their liver.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Third Affiliated Hospital, Sun Yat-Sen University (other) |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04231565 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy and safety of nucleoside analogues in treating patients with Hepatitis B who have normal levels of Alanine Aminotransferase (ALT) and positive Hepatitis B virus DNA. The research aims to address the gap in current clinical guidelines, which do not recommend antiviral therapy for this patient group despite evidence linking viral replication to increased risks of cirrhosis and liver tumors. By using Tenofovir alafenamide Fumarate, the study seeks to reduce HBV viral load, minimize inflammation, and promote liver cell regeneration. The treatment is noted for its low adverse reaction rate, enhancing its safety profile.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 with positive Hepatitis B surface antigen and normal ALT levels.
Not a fit: Patients with other active liver diseases, malignancies, or those who have received antiviral treatment in the past six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with Hepatitis B by reducing the risk of severe liver complications.
How similar studies have performed: Previous studies have shown promise in using nucleoside analogues for Hepatitis B treatment, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
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: Qiumin Luo, Doctor
- Email: lqiumin@126.com
- Phone: +8613632399075
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.
Conditions: Hepatitis B Virus, hepatitis B virus, nucleoside, nucleotide