NCT06803368Recruiting
Research on Clinical Recovery and Maintenance Strategies for CHB
Research on Clinical Recovery and Maintenance Strategies for Chronic Hepatitis B
Source: ClinicalTrials.gov · Last updated 31 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 285 (estimated)
- First submitted
- 26 Jan 2025
- Start date
- 1 Nov 2024
- Primary completion date
- 30 Oct 2027
- Lead sponsor
- Beijing Municipal Administration of Hospitals
- Diseases
- Hepatitis B
- NCT number
- NCT06803368
What you commit to
- Study type: Interventional
- Planned participants: 285
- From 1 Nov 2024 to the primary completion date, 30 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Long term alcohol abuse and/or other liver damaging drugs;
Other illness
- Merge with other hepatitis virus (HCV, HDV) infections;
- Autoimmune liver disease;
- HIV infection;
- Mental illness;
- Evidence of liver tumors (liver cancer or AFP\>100ng/ml);
- Individuals with serious diseases of the heart, brain, lungs, kidneys, and other systems who cannot participate in long-term follow-up.
Other
- Decompensated cirrhosis;
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Ditan Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.