NCT06357806Active, not recruiting
The Treatment of PD-1 Antibody Combined With Peg-IFNα in NAs-suppressed CHB Patients
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
Source: ClinicalTrials.gov · Last updated 18 Mar 2026
Brief summary (registry, in English)
This is a prospective, open-labled, randomized controlled study to assess efficacy and safety of treatment with Sintilimab (PD-1 antibody) combined Peg-IFNα-2b in CHB patients on stable NAs treatment.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 20 Mar 2024
- Start date
- 17 May 2024
- Primary completion date
- 8 Oct 2026
- Lead sponsor
- Beijing 302 Hospital
- Diseases
- Hepatitis B
- NCT number
- NCT06357806
What you commit to
- Study type: Interventional
- Planned participants: 45
- From 17 May 2024 to the primary completion date, 8 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients received interferon therapy within 12 months;
- Patients received immunosuppressive therapy or other therapy influenced study within 12 months;
- Alcohol or drug abuse/dependence;
Other illness
- History of or suspicion of hepatocellular carcinoma
- Hepatitis A, hepatitis C, hepatitis D, HIV infection or other active infections;
Lab values
- 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;
Other
- Cirrhosis;
- Investigator judges that the participants are not suitable for this study.
Who the study is looking for
- 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);
- Treatment with NAs (ETV, TDF or TAF）at least 1 years and continue NAs therapy during screening;
- HBV DNA and HBeAg turn negative after NAs treatment;
- HBsAg ranged 200-1000 IU/ml.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Fifth Medical Center, Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.