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

Not Applicable

Recruiting

• Conditions: Chronic Hepatitis B
• Interventions: Drug: Sintilimab; Drug: NAs; Drug: Peg-IFNα-2b

• Registration Number: NCT06457477
• Lead Sponsor: Beijing 302 Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-10
• Study First Submitted QC: 2024-06-10
• Study First Posted: 2024-06-13
• Study Start: 2024-06-15
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-20
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PD-1 antibody therapy	Sintilimab	-
PD-1 antibody therapy	NAs	-
PD-1 antibody therapy	Peg-IFNα-2b	-

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events/serious adverse events	48 weeks	Evaluate the treatment-emergent adverse events/serious adverse events
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.

Secondary Outcome Measures

Name	Time	Method
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 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 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
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)

Trial Locations

Locations (1)

the Fifth Medical Center, Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China