Research on Clinical Recovery and Maintenance Strategies for Chronic Hepatitis B

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Ditan Hospital
RECRUITING
Beijing
Contact Information
Primary
Lu Zhang
zhanglu1218@126.com
13581975577
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2027-10-30
Participants
Target number of participants: 285
Treatments
No_intervention: Group A:baseline anti-HBs titer≥100 mIU/ml
Patients with anti-HBs titer ≥100 mIU/ml at baseline were selected as group A
No_intervention: Group B:baseline anti-HBs titer<100 mIU/ml
Patients with anti-HBs titer\<100 mIU/ml at baseline were randomly divided into group B and group C, and group B did not receive intervention
Experimental: Group C:baseline anti-HBs titer<100 mIU/ml
Patients with anti-HBs titer\<100 mIU/ml at baseline were randomly divided into group B and group C, and group C received hepatitis B vaccine injection.
Related Therapeutic Areas
Sponsors
Leads: Beijing Municipal Administration of Hospitals

This content was sourced from clinicaltrials.gov