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

Chronic Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06457477
• Other study ID #: PIN-CHB-2
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: December 15, 2025

Study information

• Verified date: June 2024
• Source: Beijing 302 Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 15, 2025
• Est. primary completion date: December 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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-IFNa therapy, and then discontinued Peg-IFNa at least 6 months;
• 4.Patients with HBV DNA negative, HBeAg negative, HBsAg quantification = 200IU/ml at Peg-IFNa 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.

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Sintilimab
100mg/10ml/1bottle
• NAs
tablets
• Peg-IFNa-2b
180ug/0.5ml/1bottle

Locations

Country	Name	City	State
China	the Fifth Medical Center, Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing 302 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of HBsAg loss (<0.05 IU/ml) at 24 weeks and 48 weeks	Evaluate the level of HBsAg (IU/ml) at 24 weeks and 48 weeks.	48 weeks
Primary	Incidence of treatment-emergent adverse events/serious adverse events	Evaluate the treatment-emergent adverse events/serious adverse events	48 weeks
Secondary	The rate of HBsAg decline > 1log(IU/ml) at 24 weeks and 48 weeks	Evaluate the level of serum HBsAg (IU/ml) at 24 weeks and 48 weeks.	48 weeks
Secondary	The rate of HBsAb positive (>10 IU/ml) at 24 weeks and 48 weeks.	The rate of HBsAb positive (>10 IU/ml) at 24 weeks and 48 weeks.	48 weeks
Secondary	The concentration of HBcrAg (logU/mL) at baseline, 12 weeks, 24 weeks and 48 weeks	Evaluate the level of serum HBcrAg (logU/mL) at baseline, 12 weeks, 24 weeks and 48 weeks.	48 weeks
Secondary	The concentration of pgRNA (>10 IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks	Evaluate the level of serum pgRNA (>10 IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks	48 weeks
Secondary	The concentration of anti-HBc (IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks	Evaluate the level of serum anti-HBc (IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks	48 weeks
Secondary	Immune response of T cell, B cell, NK cell at baseline, 12 weeks, 24 weeks and 48 weeks	Evaluate the frequency and function of T cell, B cell, NK cell (tested by flowcytometry/fluorospot/elispot)	48 weeks