Sequential PD-1 Antibody and Pegylated Interferon Therapy for Nucleos(t)Ide Analogue-suppressed Chronic Hepatitis B

NCT07809165 | Not Yet Recruiting

• 1 other identifier: KY-2026-7-122-2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief Summary

This is a prospective, multicenter, randomized, open-label controlled clinical trial designed to evaluate the efficacy and safety of a sequential treatment strategy incorporating a PD-1 antibody and pegylated interferon-α (Peg-IFNα) in patients with chronic hepatitis B receiving stable nucleos(t)ide analogue (NA) therapy.

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (2)

• The rate of patients with HBsAg loss at Weeks 24 and 48

  48weeks

• Incidence of treatment-emergent adverse events/serious adverse events

  48weeks

Secondary Outcomes (8)

• The rate of patients with HBsAg decline > 1log(IU/ml) at Weeks 24 and 48

  48 weeks

• The rate of patients with HBsAb positive at Weeks 24 and 48.

  48 weeks

• The concentration of HBcrAg at baseline, at weeks 12, 24 and 48.

  48 weeks

• The concentration of pgRNA at baseline, at weeks 12,24 and 48.

  48 weeks

• The concentration of anti-HBc at baseline, at weeks 12,24 and 48.

  48 weeks

Study Arms (2)

Sequential PD-1 Antibody and Peg-IFNα

EXPERIMENTAL

Participants will continue background nucleos(t)ide analogue therapy throughout the study. During Weeks 0-12, participants will receive the PD-1 antibody plus NAs. Peg-IFNα will be added at Week 12, resulting in triple therapy with the PD-1 antibody, Peg-IFNα, and NAs during Weeks 12-24. After completion of PD-1 antibody treatment at Week 24, participants will continue Peg-IFNα plus NAs through Week 48.

Drug: Sintilimab; Drug: Pegylated Interferon-α 2b; Drug: Nucleos(t)ide Analogues

Peg-IFNα

ACTIVE COMPARATOR

Participants will receive Peg-IFNα in combination with continued background nucleos(t)ide analogue therapy from baseline through Week 48.

Drug: Pegylated Interferon-α 2b; Drug: Nucleos(t)ide Analogues

Interventions

Sintilimab DRUG

Sintilimab will be administered intravenously at a dose of 1.0 mg/kg at Weeks 0, 6, 12, and 18, for a total of four doses.

Sequential PD-1 Antibody and Peg-IFNα

Nucleos(t)ide Analogues DRUG

Background nucleos(t)ide analogue therapy with entecavir, tenofovir disoproxil fumarate, or tenofovir alafenamide will be continued throughout the study.

Also known as: ETV, TDF, TAF

Sequential PD-1 Antibody and Peg-IFNα

Pegylated Interferon-α 2b DRUG

Peg-IFNα will be administered subcutaneously once weekly from Week 12 through Week 48. Dose: 135 μg or 180 μg, according to the study protocol. When sintilimab and Peg-IFNα are scheduled during the same treatment period, administration of the two drugs will be separated by at least 72 hours.

Sequential PD-1 Antibody and Peg-IFNα

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Aged 18-55 years;
• Chronic hepatitis B patients with clear diagnosis of hematology, etiology and clinical (for example: HBsAg positive for more than 6 months);
• \. Treatment with NAs(ETV, TDF or TAF)at least 1 years and continue NAs therapy during screening;
• Patients with HBV DNA negative, HBeAg negative, HBsAg quantification ≤ 500IU/ml .

You may not qualify if:

• \. Cirrhosis;
• platelet count \< 90×10\^9/L, WBC count \< 3.0×10\^9/L, ALT /AST\> ULN (40U/L), total bilirubin \> 2ULN;
• History of or suspicion of hepatocellular carcinoma
• Patients received interferon therapy within 6 months;
• Patients received immunosuppressive therapy or other therapy influenced study within 6 months;
• Pregnancy
• Hepatitis A, hepatitis C, hepatitis D, HIV infection or other active infections;
• Presence of severe uncontrolled diseases of respiratory, cardiovascular or other organ systems;
• Alcohol or drug abuse/dependence;
• Other conditions rendering subjects ineligible for enrollment, including but not limited to absolute contraindications to interferon therapy, known hypersensitivity to any study drug or their excipients, and anticipated poor compliance with treatment and follow-up procedures.

Sponsors & Collaborators

• Beijing 302 Hospital: lead

Study Sites (4)

Shandong Public Health Clinical Center

Jinan, China

Location

The Third People's Hospital of Taiyuan

Taiyuan, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

sintilimab

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

• Junliang Fu

  Beijing 302 Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junliang Fu

CONTACT

86-10-66933214; fjunliang@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: September 9, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: September 9, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)