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

NCT ID: NCT06777173

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2026-11-01

Brief Summary

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.

Detailed 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.

Conditions

Chronic Hepatitis b; Immunotherapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

NAs combined with PegIFNa-2b therapy

Group Type: EXPERIMENTAL

Peg interferon alfa-2b

Intervention Type: DRUG

NA combined with Peg interferon alfa-2b

Interventions

Peg interferon alfa-2b

NA combined with Peg interferon alfa-2b

Intervention Type: DRUG

Other Intervention Names

NA combined with Peg interferon alfa-2b

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Beijing Ditan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yao Xie

Head of Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yao Xie, Doctor

Role: PRINCIPAL_INVESTIGATOR

Beijing Ditan Hospital

Locations

Beijing Ditan hospital

Beijing, , China

Countries

China

Other Identifiers

2023YFC2308105

Identifier Type: -

Identifier Source: org_study_id