NCT06803368 Research on Clinical Recovery and Maintenance Strategies for CHB
| NCT ID | NCT06803368 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Municipal Administration of Hospitals |
| Condition | Chronic Hepatitis b |
| Study Type | INTERVENTIONAL |
| Enrollment | 285 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2027-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 285 participants in total. It began in 2024-11-01 with a primary completion date of 2027-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Collect basic information of patients before antiviral treatment and when HBsAg disappears, and divide them into three groups A, B, and C based on baseline anti HBs titers after informed consent. During the follow-up period of all patients, clinical biochemistry, virology (HBVDNA, HBVRNA), serological indicators (HBsAg, anti HBs, HBeAg, anti HBe, HBcrAg, anti HBc), AFP, Fibroscan, liver imaging examinations will be conducted every 3-6 months, and blood samples will be retained for monitoring the frequency of immune cells (pDC, Treg) and the expression of functional molecules, as well as cytokines (IFN - γ, IP-10, IL-10, and TGF - β). Observe the sustained response rate and recurrence rate of virological and serological indicators, as well as the incidence of hepatitis and liver cancer during the follow-up period.
Eligibility 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.
Contact & Investigator
Minghui Li
PRINCIPAL INVESTIGATOR
Beijing Ditan Hospital
Frequently Asked Questions
Who can join the NCT06803368 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Chronic Hepatitis b. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06803368 currently recruiting?
Yes, NCT06803368 is actively recruiting participants. Contact the research team at zhanglu1218@126.com for enrollment information.
Where is the NCT06803368 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06803368 clinical trial?
NCT06803368 is sponsored by Beijing Municipal Administration of Hospitals. The principal investigator is Minghui Li at Beijing Ditan Hospital. The trial plans to enroll 285 participants.