NCT06357806

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
May 2024Oct 2026

First Submitted

Initial submission to the registry

March 20, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

May 17, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2026

Last Updated

March 18, 2026

Status Verified

October 1, 2025

Enrollment Period

2.4 years

First QC Date

March 20, 2024

Last Update Submit

March 16, 2026

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (2)

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

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

    48 weeks

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

    Evaluate the treatment-emergent adverse events/serious adverse events

    48 weeks

Secondary Outcomes (6)

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

    48 weeks

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

    48 weeks

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

    48 weeks

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

    48 weeks

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

    48 weeks

  • +1 more secondary outcomes

Study Arms (3)

Peg-IFNα group

ACTIVE COMPARATOR

180 ug Peg-IFNα-2b subcutaneous injection once/week for 48 weeks NAs

Drug: Peg-IFNα-2bDrug: NAs

PD-1 antibody group

ACTIVE COMPARATOR

1.5 mg/kg Sintilimab intravenous injection once per 3 weeks for 24 weeks NAs

Drug: SintilimabDrug: NAs

PD-1 antibody combined Peg-IFNα group

EXPERIMENTAL

1.5 mg/kg Sintilimab intravenous injection once per 3 weeks for 24 weeks 180 ug Peg-IFNα-2b subcutaneous injection once/week for 48 weeks NAs

Interventions

NAsDRUG

tablets

Also known as: ETV/TDF/TAF
PD-1 antibody groupPeg-IFNα group
SintilimabDRUG

100mg/10ml/1bottle

PD-1 antibody group
Peg-IFNα-2bDRUG

180ug/0.5ml/1bottle

Peg-IFNα group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Fifth Medical Center, Chinese PLA General Hospital

Beijing, Beijing Municipality, 100039, China

Location

Related Publications (1)

  • Wang H, Li X, Lu J, Zhang X, Dang S, Li Y, He Y, Guo Y, Wang J, Maimaitijiang W, Zheng S, Ren S, Cao H, Zhang W, Zhang X, Ma H, Wang FS, Fu J. Safety and efficacy of PD-1 antibody combined with pegylated interferon alpha for functional cure in nucleos(t)ide analogues-suppressed chronic hepatitis B patients: protocol for a multicentre randomised controlled trial. BMJ Open. 2025 Sep 21;15(9):e105710. doi: 10.1136/bmjopen-2025-105710.

    PMID: 40976664DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

sintilimabnas

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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

March 20, 2024

First Posted

April 10, 2024

Study Start

May 17, 2024

Primary Completion (Estimated)

October 8, 2026

Study Completion (Estimated)

October 8, 2026

Last Updated

March 18, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)