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

Chronic Hepatitis B Clinical Trial

Official title:

The Safety and Efficacy of PD-1 Antibody Combined With Pegylated Interferon-α Therapy to Promote the Clinical Cure in Nucleoside (Acid) Analogues-suppressed Chronic Hepatitis B Patients: A Protocol for the Prospective Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06357806
• Other study ID #: PIN-CHB-1
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: October 30, 2025

Study information

• Verified date: March 2024
• Source: Beijing 302 Hospital
• Contact: Junliang Fu
• Phone: 86-10-66933214
• Email: fjunliang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, open-labled, randomized controlled study to assess efficacy and safety of treatment with Sintilimab (PDL-1 antibody) combined Peg-IFNα-2b in CHB patients on stable NAs treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: October 30, 2025
• Est. primary completion date: October 30, 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. 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.

Related Conditions & MeSH terms

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

Intervention

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

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 at 24 weeks and 48 weeks.	Evaluate the level of HBsAg 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 at 24 weeks and 48 weeks.	48 weeks
Secondary	The rate of HBsAb positive at 24 weeks and 48 weeks.	Evaluate the level of serum HBsAb at 24 weeks and 48 weeks.	48 weeks
Secondary	The concentration of HBcrAg at baseline, 12 weeks, 24 weeks and 48 weeks.	Evaluate the level of serum HBcrAg at baseline, 12 weeks, 24 weeks and 48 weeks.	48 weeks
Secondary	The concentration of pgRNA at baseline, 12 weeks, 24 weeks and 48 weeks.	Evaluate the level of serum pgRNA at baseline, 12 weeks, 24 weeks and 48 weeks.	48 weeks
Secondary	The concentration of anti-HBc at baseline, 12 weeks, 24 weeks and 48 weeks.	Evaluate the level of serum anti-HBc 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