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

Beijing 302 Hospital

Status: Enrolling

Conditions: Chronic Hepatitis B

Treatments: Drug: Peg-IFNα-2b; Drug: NAs; Drug: Sintilimab

Study type: Interventional

Funder types: Other

Identifiers

NCT06357806

PIN-CHB-1

Details and patient eligibility

About

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.

Enrollment: 45 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);
3. Treatment with NAs (ETV, TDF or TAF）at least 1 years and continue NAs therapy during screening;
4. HBV DNA and HBeAg turn negative after NAs treatment;
5. HBsAg ranged 200-1000 IU/ml.

Exclusion criteria

1. Cirrhosis;
2. 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;
3. History of or suspicion of hepatocellular carcinoma
4. Patients received interferon therapy within 12 months;
5. Patients received immunosuppressive therapy or other therapy influenced study within 12 months;
6. Hepatitis A, hepatitis C, hepatitis D, HIV infection or other active infections;
7. Alcohol or drug abuse/dependence;
8. Investigator judges that the participants are not suitable for this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Peg-IFNα group

Active Comparator group

Description:

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

Treatment:

Drug: NAs

Drug: Peg-IFNα-2b

PD-1 antibody group

Active Comparator group

Description:

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

Treatment:

Drug: Sintilimab

Drug: NAs

PD-1 antibody combined Peg-IFNα group

Experimental group

Description:

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

Treatment:

Drug: Sintilimab

Drug: NAs

Drug: Peg-IFNα-2b