Combining PD-1 antibody with Peg-IFNα for treating chronic hepatitis B
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
This study is testing if combining a new antibody treatment with an existing medication can help people with chronic hepatitis B who are already on other treatments feel better and manage their virus more effectively.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Beijing 302 Hospital Academic / other |
| Drugs / interventions | Sintilimab |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06357806 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of Sintilimab, a PD-1 antibody, in combination with Peg-IFNα-2b for patients with chronic hepatitis B who are currently on nucleos(t)ide analogs (NAs) treatment. It is a prospective, open-label, randomized controlled study that aims to determine if this combination therapy can improve patient outcomes. Participants will be monitored for their response to the treatment over a specified period, focusing on viral suppression and safety profiles.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with chronic hepatitis B who have been on stable NAs treatment for at least one year.
Not a fit: Patients with cirrhosis, significant blood count abnormalities, or those with a history of hepatocellular carcinoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective option for managing chronic hepatitis B, potentially leading to better viral control and improved liver health.
How similar studies have performed: While this approach is innovative, similar studies combining immune checkpoint inhibitors with antiviral therapies have shown promise in other viral infections, suggesting potential for success.
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. 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.
Where this trial is running
Beijing, Beijing
- the Fifth Medical Center, Chinese PLA General Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Junliang Fu
- Email: fjunliang@163.com
- Phone: 86-10-66933214
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.