Combination therapy for chronic hepatitis B patients
The Safety and Efficacy of Sequential Combination Therapy With PD-1 Antibody and Pegylated Interferon-α in NA-supressed Chronic Hepatitis B Patients
This study is testing if a new combination of treatments can help people with chronic hepatitis B who haven't responded well to previous therapy feel better and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Beijing 302 Hospital Academic / other |
| Drugs / interventions | Sintilimab |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06457477 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of Sintilimab, a PD-1 antibody, in combination with Peg-IFNα-2b for patients with chronic hepatitis B who have been virologically suppressed by nucleos(t)ide analogs. Participants must have previously received Peg-IFNα therapy and show limited response to it. The study aims to determine if this sequential treatment can improve patient outcomes. It is a prospective interventional study focusing on a specific patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with chronic hepatitis B who have been virologically suppressed and previously treated with Peg-IFNα.
Not a fit: Patients with cirrhosis, significant blood count abnormalities, or other active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective therapy option for patients with chronic hepatitis B.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using combination therapies for chronic hepatitis B.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing Municipality
- the Fifth Medical Center, Chinese PLA General Hospital — Beijing, Beijing Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.