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

Beijing 302 Hospital

Status

Enrolling

Conditions

Chronic Hepatitis B

Treatments

Drug: Sintilimab

Drug: Peg-IFNα-2b

Drug: NAs

Study type

Interventional

Funder types

Other

Identifiers

NCT06457477

PIN-CHB-2

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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);
1. 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.