Observing effects after stopping hepatitis B treatment
Clinical Investigation About Therapeutic Effects and Long-term Follow-up After Ending Anti-hepatitis B Virus Therapy With Nucleos(t)Ide Analogs in Patients With Chronic Hepatitis b
This study looks at what happens to people with chronic hepatitis B after they stop their treatment to see how their health changes over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Third Affiliated Hospital, Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT02883647 on ClinicalTrials.gov |
What this trial studies
This study observes the therapeutic effects and long-term outcomes in patients with chronic hepatitis B after they discontinue treatment with nucleos(t)ide analogs. It involves monitoring various health parameters, including symptoms, laboratory test results, and the occurrence of liver-related complications. The study aims to assess the relapse rates and the need for retreatment in these patients over time.
Who should consider this trial
Good fit: Ideal candidates are patients who have been on nucleos(t)ide analog therapy for at least two years and meet specific virological criteria.
Not a fit: Patients with liver cirrhosis, hepatocellular carcinoma, or other significant liver diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term management of chronic hepatitis B after therapy cessation.
How similar studies have performed: While there have been studies on hepatitis B treatment, this specific observational approach focusing on post-therapy outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients received anti-HBV therapy with nucleos(t)ide analogs. 2. Last anti-HBV therapy should continue for at least 2 years. 3. For HBeAg positive patients, HBV DNA should keep negative for at least 1 year after HBeAg seroconversion before the therapy ending; for HBeAg negative patients, HBV DNA should keep negative for at least 2 years before the therapy ending. Exclusion Criteria: 1. Liver cirrhosis, HCC; 2. Patients with other factors causing active liver diseases; 3. Pregnancy or lactation; 4. Patients with HIV infection or congenital immune deficiency diseases; 5. Patients with severe diabetes, autoimmune diseases, other important organ dysfunctions and other serious complications.
Where this trial is running
Guangzhou, Guangdong
- The 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, Master
- 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.