Clinical Study of Antiviral Therapy Combined With Novel Immunotherapy for CHB in Adults

Capital Medical University

Status

Invitation-only

Conditions

Chronic Hepatitis b

Immunotherapy

Treatments

Drug: Peg interferon alfa-2b

Study type

Interventional

Funder types

Other

Identifiers

NCT06777173

2023YFC2308105

Details and patient eligibility

About

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.

Full description

This research group established an adult randomized controlled study cohort corresponding to the children cohort: 1 immunetolerance (IT) and 1 immuneclearance (IC) antiviral treatment cohort, respectively according to 1: 1 Randomly divided into two intervention groups: nucleoside (acid) analogues (NAs) and NAs combined with pegylated interferon α-2b (PegIFNα-2b). 1 NAs treatment-advantaged population antiviral combined with novel immunotherapy cohort: PD-1 antibody, PegIFNα-2b and combination group were randomly enrolled 1:1:1, and the response guidance treatment plan was adjusted according to the response of patients during treatment, the HBsAg clearance rate at 24 weeks and 48 weeks of different optimal treatment groups was evaluated, the clinical curative characteristics and differences between children and adults were compared, and the key factors affecting clinical cure were screened. 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.

Enrollment

180 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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;
Alcoholics or drug users who have not abstained;
Have uncontrolled diabetes, hypertension, thyroid disease, retinopathy, autoimmune disease, etc.