Research on recovery and maintenance strategies for chronic hepatitis B
Research on Clinical Recovery and Maintenance Strategies for Chronic Hepatitis B
NA · Beijing Municipal Administration of Hospitals · NCT06803368
This study is testing different treatment strategies for people with chronic hepatitis B to see how well they help manage the condition and prevent liver problems.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 285 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Beijing Municipal Administration of Hospitals (other gov) |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06803368 on ClinicalTrials.gov |
What this trial studies
This study collects baseline information from chronic hepatitis B patients before antiviral treatment and monitors them until HBsAg disappears. Patients are divided into three groups based on their baseline anti-HBs titers, with one group receiving a recombinant hepatitis B vaccine. Follow-up assessments include clinical biochemistry, virology, serological indicators, and immune cell monitoring every 3-6 months to evaluate sustained response rates and the incidence of liver-related complications. The goal is to understand the effectiveness of different treatment strategies in managing chronic hepatitis B.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with chronic hepatitis B who have achieved HBsAg disappearance after interferon treatment.
Not a fit: Patients with co-infections, autoimmune liver diseases, or serious comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies for chronic hepatitis B, potentially reducing the incidence of liver cancer and other complications.
How similar studies have performed: Other studies have shown promise in using vaccination strategies for chronic hepatitis B, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 65 years old; * Gender is not limited; * CHB patients who meet the diagnostic criteria of the 2019 edition of the Guidelines for the Prevention and Treatment of Chronic Hepatitis B \[5\]; * Confirmed interferon treatment resulted in HBsAg disappearance, HBeAg negativity, and HBV DNA below the lower detection limit and cessation Patients treated with interferon; * Sign a written informed consent form. Exclusion Criteria: * Merge with other hepatitis virus (HCV, HDV) infections; * Autoimmune liver disease; * HIV infection; * Long term alcohol abuse and/or other liver damaging drugs; * Mental illness; * Evidence of liver tumors (liver cancer or AFP\>100ng/ml); * Decompensated cirrhosis; * Individuals with serious diseases of the heart, brain, lungs, kidneys, and other systems who cannot participate in long-term follow-up.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Ditan Hospital — Beijing, Beijing Municipality, China (RECRUITING)
Study contacts
- Principal investigator: Minghui Li — Beijing Ditan Hospital
- Study coordinator: Lu Zhang
- Email: zhanglu1218@126.com
- Phone: 13581975577
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: Chronic Hepatitis b, Hepatitis B Vaccine