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

January 10, 2025 updated by: Yao Xie, Beijing Ditan Hospital

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Beijing Ditan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
NAs combined with PegIFNa-2b therapy
Drug: Peg interferon alfa-2b
NA combined with Peg interferon alfa-2b
Other Names:
  • NA combined with Peg interferon alfa-2b

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HBsAg clearance at 48 weeks.
Time Frame: 48weeks
HBsAg clearance in enrolled patients at week 48.（The detection of serum HBV markers is carried out using a HBsAg quantitative Elecsys （Roche Diagnostics GmbH, German）, with a HBsAg quantitative detection limit of 0.05IU/mL.）
48weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum HBsAg clearance or conversion rates at week 24, week 72, and week 24 after drug withdrawal
Time Frame: 24 weeks,72 weeks
Serum HBsAg clearance or conversion rates.（The detection of serum HBV markers is carried out using a HBsAg quantitative Elecsys （Roche Diagnostics GmbH, German）, with a HBsAg quantitative detection limit of 0.05IU/mL.）
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
HBeAg conversion rate.（The detection of serum HBV markers is carried out using a HBsAg quantitative Elecsys （Roche Diagnostics GmbH, German）, with a HBsAg quantitative detection limit of 0.05IU/mL.）
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 degree of serum HBsAg and HBeAg reduction from baseline.（The detection of serum HBV markers is carried out using a HBsAg quantitative Elecsys （Roche Diagnostics GmbH, German）, with a HBsAg quantitative detection limit of 0.05IU/mL.）
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
The proportion of serum HBVDNA lower than the lower limit of detection.（HBV DNA detection: Real time fluorescent quantitative PCR system is used for detection, with a detection limit of 10 IU/ml.）
24 weeks,48 weeks,72 weeks
Evaluation of drug safety during treatment
Time Frame: 36 months
Evaluation of drug safety during treatment.(The rate of adverse reactions experienced by patients during medication use.)
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Ditan Hospital

Investigators

  • Principal Investigator: Yao Xie, Doctor, Beijing Ditan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

November 24, 2024

First Submitted That Met QC Criteria

January 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 10, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023YFC2308105

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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