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

NCT06457477 — Not applicable, Unknown, 50 participants, Beijing 302 Hospital

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

Registry	NCT06457477
Status	Unknown
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	50 (Estimated)
Sponsor	Beijing 302 Hospital (Other)
Conditions	Chronic Hepatitis B
Interventions	Sintilimab, NAs, Peg-IFNα-2b (Drug)
Dates	start 2024-06-15 (estimated), primary completion 2025-12-15 (estimated), completion 2025-12-15 (estimated), first posted 2024-06-13, last updated 2024-06-20
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
PD-1 antibody therapy	Experimental	Drug: Sintilimab; Drug: NAs; Drug: Peg-IFNα-2b

Sintilimab (Drug): 100mg/10ml/1bottle
NAs (Drug), also known as ETV/TDF/TAF: tablets
Peg-IFNα-2b (Drug): 180ug/0.5ml/1bottle

+Outcome measures

Primary outcomes

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 outcomes

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.
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.
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 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
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)

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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.

+Locations (1)

Facility	City	Country	Status
the Fifth Medical Center, Chinese PLA General Hospital	Beijing, Beijing Municipality	China	Recruiting

+Publications

Results publication: Wang H, Zhang C, Li X, Li Y, Zhang X, Xu R, Wang K, Lv S, Fan X, Wang Q, Liu S, Yang S, Zhang X, Dang S, Wang FS, Fu J. Sequential combination of anti-PD-1 antibody and PEG-IFNalpha in chronic hepatitis B patients: correlates of HBsAg loss with enhanced T-cell responses. Emerg Microbes Infect. 2026 Dec;15(1):2735154. doi: 10.1080/22221751.2026.2735154. Epub 2026 Sep 25. PMID 42789423