Clinical trial NCT06777173: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Chronic Hepatitis b
Immunotherapy
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: HBsAg clearance at 48 weeks.
timeFrame: 48weeks
Secondary outcomes:
measure: Serum HBsAg clearance or conversion rates at week 24, week 72, and week 24 after drug withdrawal
timeFrame: 24 weeks,72 weeks
measure: HBeAg conversion rate at week 24, 48, 72 and 24 weeks after drug withdrawal
timeFrame: 24 weeks,48 weeks,72 weeks
measure: The degree of serum HBsAg and HBeAg reduction from baseline at week 24, 48, 72 and 24 weeks after drug withdrawal
timeFrame: 24 weeks,48 weeks,72 weeks
measure: The proportion of serum HBVDNA lower than the lower limit of detection at week 24, 48, 72 and 24 weeks after drug withdrawal
timeFrame: 24 weeks,48 weeks,72 weeks
measure: Evaluation of drug safety during treatment
timeFrame: 36 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan hospital
Study officials:
affiliation: Beijing Ditan Hospital
name: Yao Xie, Doctor
role: PRINCIPAL_INVESTIGATOR
References: