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Clinical Trials in China / NCT07809165
Starting soon Not applicable

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

NCT07809165 · tracked via the Priya Life Science China tracker
Sponsor
Beijing 302 Hospital
Phase
Not applicable
Started
2026-09
Last updated
2026-09-09

Condition(s) studied

Chronic Hepatitis B

Investigational drug(s) / intervention(s)

Sintilimab →Pegylated Interferon-α 2b →Nucleos(t)ide AnaloguesPegylated Interferon-α 2b →Nucleos(t)ide Analogues

Sintilimab: 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.

Pegylated Interferon-α 2b: 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.

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

Pegylated Interferon-α 2b: Peg-IFNα will be administered subcutaneously once weekly from Week 0 through Week 48. Dose: 135 μg or 180 μg, according to the study protocol.

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
Inclusion Criteria: * 1\. Aged 18-55 years; * 2.Chronic hepatitis B patients with clear diagnosis of hematology, etiology and clinical (for example: HBsAg positive for more than 6 months); * 3\. Treatment with NAs(ETV, TDF or TAF)at least 1 years and continue NAs therapy during screening; * 4.Patients with HBV DNA negative, HBeAg negative, HBsAg quantification ≤ 500IU/ml . Exclusion Criteria: * 1\. Cirrhosis; * 2.platelet count \< 90×10\^9/L, WBC count \< 3.0×10\^9/L, ALT /AST\> ULN (40U/L), total bilirubin \> 2ULN; * 3.History of or suspicion of hepatocellular carcinoma * 4.Patients received interferon therapy within 6 months; * 5.Patients received immunosuppressive therapy or other therapy influenced study within 6 months; * 6.Pregnancy * 7.Hepatitis A, hepatitis C, hepatitis D, HIV infection or other active infections; * 8.Presence of severe uncontrolled diseases of respiratory, cardiovascular or other organ systems; * 9.Alcohol or drug abuse/dependence; * 10.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.

Primary outcome measure(s)

  • The rate of patients with HBsAg loss at Weeks 24 and 48 — 48weeks
  • Incidence of treatment-emergent adverse events/serious adverse events — 48weeks

Trial sites (4)

FacilityCityRegionStatus
Shandong Public Health Clinical Center Jinan China
The Third People's Hospital of Taiyuan Taiyuan China
The First Affiliated Hospital of Xi'an Jiaotong University Xi'an China
The Second Affiliated Hospital of Xi'an Jiaotong University Xi'an China

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VA-CIG Regimen for Previously Untreated Acute Myeloid Leukemia: A Multicenter Prospective Single-Arm Trial Recruiting

Other trials for the same condition

A Phase II Clinical Study of BW-20507 in Combination With PEG-IFNα for the Treatment of Hepatitis B Active, not recruiting
Tenofovir Alafenamide Switching Therapy in Kidney or Liver Transplant Recipients With Chronic HBV Infection Active, not recruiting
Clinical Outcomes of HBeAg-negative CHB Patients With Indeterminate Phase Recruiting
Study to Evaluate the Efficacy and Safety of AHB-137 in Treatment-naive Participants With Chronic Hepatitis B (CHB) Active, not recruiting
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B. Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07809165 on ClinicalTrials.gov ↗ ← All trials in China