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

Official title

Clinical Study of Antiviral Therapy Combined With Novel Immunotherapy for Chronic Hepatitis B in Adults

Overview

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.

Interventions

• Drug Peg interferon alfa-2b
  NA combined with Peg interferon alfa-2b

Primary outcome measures

• HBsAg clearance at 48 weeks. [Time frame: 48weeks]

Secondary outcome measures (5)

• Serum HBsAg clearance or conversion rates at week 24, week 72, and week 24 after drug withdrawal [Time frame: 24 weeks,72 weeks]
• HBeAg conversion rate at week 24, 48, 72 and 24 weeks after drug withdrawal [Time frame: 24 weeks,48 weeks,72 weeks]
• The degree of serum HBsAg and HBeAg reduction from baseline at week 24, 48, 72 and 24 weeks after drug withdrawal [Time frame: 24 weeks,48 weeks,72 weeks]
• The proportion of serum HBVDNA lower than the lower limit of detection at week 24, 48, 72 and 24 weeks after drug withdrawal [Time frame: 24 weeks,48 weeks,72 weeks]
• Evaluation of drug safety during treatment [Time frame: 36 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Beijing Ditan hospital — Beijing

Identifiers

NCT: NCT06777173 · 2023YFC2308105

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗