Sequential Combination Therapy With PD-1 Antibody and Peg-IFNα in CHB Patients

The Safety and Efficacy of Sequential Combination Therapy With PD-1 Antibody and Pegylated Interferon-α in NA-supressed Chronic Hepatitis B Patients

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06457477

Enrollment

Registered

2024-06-13

Start date

2024-06-15

Completion date

2025-12-15

Last updated

2024-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Brief summary

This is a prospective study to evaluate the safety and efficacy of Sintilimab (PD-1 antibody) in sequential combination with Peg-IFNα-2b in NA-supressed CHB patients who had previously received Peg-IFNα therapy.

Interventions

DRUGSintilimab

100mg/10ml/1bottle

DRUGNAs

tablets

DRUGPeg-IFNα-2b

180ug/0.5ml/1bottle

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 1\. 18 - 65 years old; * 2.Chronic hepatitis B patients with clear diagnosis of hematology, etiology and clinical (for example: HBsAg positive for more than 6 months); * 3\. In virologically suppressed (HBV DNA below the lower detection limit) CHB patients by NAs treatment, HBsAg decreased by less than 0.5log in the last 6 months of Peg-IFNα therapy, and then discontinued Peg-IFNα at least 6 months; * 4.Patients with HBV DNA negative, HBeAg negative, HBsAg quantification ≤ 200IU/ml at Peg-IFNα discontinuation and enrollment.

Exclusion criteria

* 1\. Cirrhosis; * 2.platelet count \< 90×109/L, WBC count \< 3.0×109/L, neutrophil count \< 1.3×109/L, ALT \> ULN (40U/L), total bilirubin \> 2ULN; * 3.History of or suspicion of hepatocellular carcinoma * 4.Patients received immunosuppressive therapy or other therapy influenced study within 12 months; * 5.Hepatitis A, hepatitis C, hepatitis D, HIV infection or other active infections; * 6.Alcohol or drug abuse/dependence; * 7.Investigator judges that the participants are not suitable for this study.

Design outcomes

Primary

Measure	Time frame	Description
The rate of HBsAg loss (<0.05 IU/ml) at 24 weeks and 48 weeks	48 weeks	Evaluate the level of HBsAg (IU/ml) at 24 weeks and 48 weeks.
Incidence of treatment-emergent adverse events/serious adverse events	48 weeks	Evaluate the treatment-emergent adverse events/serious adverse events

Secondary

Measure	Time frame	Description
The concentration of HBcrAg (logU/mL) at baseline, 12 weeks, 24 weeks and 48 weeks	48 weeks	Evaluate the level of serum HBcrAg (logU/mL) at baseline, 12 weeks, 24 weeks and 48 weeks.
The concentration of pgRNA (>10 IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks	48 weeks	Evaluate the level of serum pgRNA (\>10 IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks
The rate of HBsAg decline > 1log(IU/ml) at 24 weeks and 48 weeks	48 weeks	Evaluate the level of serum HBsAg (IU/ml) at 24 weeks and 48 weeks.
Immune response of T cell, B cell, NK cell at baseline, 12 weeks, 24 weeks and 48 weeks	48 weeks	Evaluate the frequency and function of T cell, B cell, NK cell (tested by flowcytometry/fluorospot/elispot)
The concentration of anti-HBc (IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks	48 weeks	Evaluate the level of serum anti-HBc (IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks
The rate of HBsAb positive (>10 IU/ml) at 24 weeks and 48 weeks.	48 weeks	The rate of HBsAb positive (\>10 IU/ml) at 24 weeks and 48 weeks.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026