Research on Clinical Recovery and Maintenance Strategies for CHB
Recruiting · NCT06803368 · Interventional (participants receive a specific treatment) · Lead sponsor: Beijing Municipal Administration of Hospitals
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
1 location listed.
- Beijing Ditan Hospital - Beijing, Beijing Municipality, China