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

NCT06457477 | Recruiting

• 1 other identifier: PIN-CHB-2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (2)

• 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

• Incidence of treatment-emergent adverse events/serious adverse events

  Evaluate the treatment-emergent adverse events/serious adverse events

  48 weeks

Secondary Outcomes (6)

• The rate of HBsAg decline > 1log(IU/ml) at 24 weeks and 48 weeks

  48 weeks

• The rate of HBsAb positive (>10 IU/ml) at 24 weeks and 48 weeks.

  48 weeks

• The concentration of HBcrAg (logU/mL) at baseline, 12 weeks, 24 weeks and 48 weeks

  48 weeks

• The concentration of pgRNA (>10 IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks

  48 weeks

• The concentration of anti-HBc (IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks

  48 weeks

Study Arms (1)

PD-1 antibody therapy

EXPERIMENTAL

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

Interventions

Sintilimab DRUG

100mg/10ml/1bottle

PD-1 antibody therapy

NAs DRUG

tablets

Also known as: ETV/TDF/TAF

PD-1 antibody therapy

Peg-IFNα-2b DRUG

180ug/0.5ml/1bottle

PD-1 antibody therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 18 - 65 years old;
• Chronic hepatitis B patients with clear diagnosis of hematology, etiology and clinical (for example: HBsAg positive for more than 6 months);
• \. 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;
• Patients with HBV DNA negative, HBeAg negative, HBsAg quantification ≤ 200IU/ml at Peg-IFNα discontinuation and enrollment.

You may not qualify if:

• \. Cirrhosis;
• platelet count \< 90×109/L, WBC count \< 3.0×109/L, neutrophil count \< 1.3×109/L, ALT \> ULN (40U/L), total bilirubin \> 2ULN;
• History of or suspicion of hepatocellular carcinoma
• Patients received immunosuppressive therapy or other therapy influenced study within 12 months;
• Hepatitis A, hepatitis C, hepatitis D, HIV infection or other active infections;
• Alcohol or drug abuse/dependence;
• Investigator judges that the participants are not suitable for this study.

Sponsors & Collaborators

• Beijing 302 Hospital: lead

Study Sites (1)

the Fifth Medical Center, Chinese PLA General Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

sintilimab; nas

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 13, 2024
• Study Start: June 15, 2024
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)