NCT06777173Enrolling by invitation
Clinical Study of Antiviral Therapy Combined With Novel Immunotherapy for CHB in Adults
Clinical Study of Antiviral Therapy Combined With Novel Immunotherapy for Chronic Hepatitis B in Adults
Source: ClinicalTrials.gov · Last updated 15 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Establish a study cohort of adult chronic hepatitis B antiviral treatment based on the principle of responseguidedtreatment (RGT) corresponding to the child cohort, analyze the clinical cure factors of IC and IT stage adults chronic hepatitis B, and optimize the antiviral treatment plan. To determine the safety and efficacy of PD-1 antibody combined with Peg-FNa-2b in the treatment of adult NAs patients with CHB advantage.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 24 Nov 2024
- Start date
- 1 Dec 2023
- Primary completion date
- 1 Nov 2026
- Lead sponsor
- Beijing Ditan Hospital
- Diseases
- Hepatitis B
- NCT number
- NCT06777173
What you commit to
- Study type: Interventional
- Planned participants: 180
- From 1 Dec 2023 to the primary completion date, 1 Nov 2026
- 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
- Alcoholics or drug users who have not abstained;
Other illness
- Patients with HAV, HCV, HEV infection and autoimmune liver disease; Pregnant and lactating women and patients who plan to give birth in the near future;
- Patients with cirrhosis or liver cancer indicated by imaging or liver hardness testing;
- A history of serious heart disease, including unstable or uncontrolled heart disease within the last 6 months;
- Have a mental illness or history of mental illness;
- Have uncontrolled seizures;
- Have uncontrolled diabetes, hypertension, thyroid disease, retinopathy, autoimmune disease, etc.
Who the study is looking for
- Age 18-65 years old；
- Meet the 2022 Chronic Hepatitis B Guidelines definition of chronic HBV infection: HBsAg and/or HBVDNA positive \>6 months;；
- Immune clearance period: HBeAg positive, HBVDNA positive, ALT\>40U/L;
- Newly treated patients;
- Willing to sign informed consent
Age in the registry: 18 years to 65 years · Sex: Female · 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 | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.