Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06357806

The Treatment of PD-1 Antibody Combined With Peg-IFNα in NAs-suppressed CHB Patients

This is a prospective, open-labled, randomized controlled study to assess efficacy and safety of treatment with Sintilimab (PD-1 antibody) combined Peg-IFNα-2b in CHB patients on stable NAs treatment.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Fifth Medical Center, Chinese PLA General Hospital

Beijing, Beijing Municipality, 100039, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 - 65 years old;
  • 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;
  • HBV DNA and HBeAg turn negative after NAs treatment;
  • HBsAg ranged 200-1000 IU/ml.

Exclusion criteria

  • Cirrhosis;
  • platelet count < 90×10^9/L, WBC count < 3.0×10^9/L, neutrophil count < 1.3×10^9/L, ALT > ULN（40U/L）, total bilirubin > 2ULN;
  • History of or suspicion of hepatocellular carcinoma
  • Patients received interferon therapy within 12 months;
  • Patients received immunosuppressive therapy or other therapy influenced study within 12 months;
  • Hepatitis A, hepatitis C, hepatitis D, HIV infection or other active infections;
  • Alcohol or drug abuse/dependence;
  • Investigator judges that the participants are not suitable for this study.

Treatment and study plan

Sintilimab

Drug

100mg/10ml/1bottle

Peg-IFNα-2b

Drug

180ug/0.5ml/1bottle

NAs

Drug

tablets

Other names: ETV/TDF/TAF

Primary outcomes

  1. The rate of HBsAg loss at 24 weeks and 48 weeks.

    Time frame: 48 weeks

    Evaluate the level of HBsAg at 24 weeks and 48 weeks.

  2. Incidence of treatment-emergent adverse events/serious adverse events

    Time frame: 48 weeks

    Evaluate the treatment-emergent adverse events/serious adverse events

Secondary outcomes

  1. The rate of HBsAg decline > 1log(IU/ml) at 24 weeks and 48 weeks

    Time frame: 48 weeks

    Evaluate the level of serum HBsAg at 24 weeks and 48 weeks.

  2. The rate of HBsAb positive at 24 weeks and 48 weeks.

    Time frame: 48 weeks

    Evaluate the level of serum HBsAb at 24 weeks and 48 weeks.

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

    Time frame: 48 weeks

    Evaluate the level of serum HBcrAg at baseline, 12 weeks, 24 weeks and 48 weeks.

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

    Time frame: 48 weeks

    Evaluate the level of serum pgRNA at baseline, 12 weeks, 24 weeks and 48 weeks.

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

    Time frame: 48 weeks

    Evaluate the level of serum anti-HBc at baseline, 12 weeks, 24 weeks and 48 weeks.

  6. Immune response of T cell, B cell, NK cell at baseline, 12 weeks, 24 weeks and 48 weeks.

    Time frame: 48 weeks

    Evaluate the frequency and function of T cell, B cell, NK cell (tested by flowcytometry/fluorospot/elispot)

Sponsors and collaborators

Lead sponsor

Beijing 302 Hospital

Other

Registry information

Official study title

The Safety and Efficacy of PD-1 Antibody Combined With Pegylated Interferon-α Therapy to Promote the Clinical Cure in Nucleoside (Acid) Analogues-suppressed Chronic Hepatitis B Patients: A Protocol for the Prospective Pilot Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 10, 2024
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.