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

NCT06777173 | Enrolling By Invitation

• 1 other identifier: 2023YFC2308105
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis b; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• HBsAg clearance at 48 weeks.

  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 Outcomes (5)

• Serum HBsAg clearance or conversion rates at week 24, week 72, and week 24 after drug withdrawal

  24 weeks,72 weeks

• HBeAg conversion rate at week 24, 48, 72 and 24 weeks after drug withdrawal

  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

  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

  24 weeks,48 weeks,72 weeks

• Evaluation of drug safety during treatment

  36 months

Study Arms (1)

Treatment Group

EXPERIMENTAL

NAs combined with PegIFNa-2b therapy

Drug: Peg interferon alfa-2b

Interventions

Peg interferon alfa-2b DRUG

NA combined with Peg interferon alfa-2b

Also known as: NA combined with Peg interferon alfa-2b

Treatment Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Ditan Hospital: lead

Study Sites (1)

Beijing Ditan hospital

Beijing, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

peginterferon alfa-2b

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yao Xie, Doctor

  Beijing Ditan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: January 15, 2025
• Study Start: December 1, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

CN (1)