Sintilimab then pegylated interferon for chronic hepatitis B already controlled with antiviral pills
Tests sintilimab followed by pegylated interferon in adults with chronic hepatitis B.
Plain-language title generated from the registry record
Registry title: Sequential PD-1 Antibody and Pegylated Interferon Therapy for Nucleos(t)Ide Analogue-suppressed Chronic Hepatitis B
Key facts
- Where
- Jinan, Taiyuan, Xi'an, and Xi’an, ChinaSee the 4 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 55 years old?
Source: NCT07809165, who can take part
Where in China
- Shandong Public Health Clinical CenterJinan, ChinaNo longer taking part
- The Third People's Hospital of TaiyuanTaiyuan, ChinaNo longer taking part
- The Second Affiliated Hospital of Xi'an Jiaotong UniversityXi'an, ChinaNo longer taking part
- The First Affiliated Hospital of Xi'an Jiaotong UniversityXi’an, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Beijing 302 Hospital
- Trial code
- NCT07809165
- Record updated
- 9 September 2026
- Original description
This is a prospective, multicenter, randomized, open-label controlled clinical trial designed to evaluate the efficacy and safety of a sequential treatment strategy incorporating a PD-1 antibody and pegylated interferon-α (Peg-IFNα) in patients with chronic hepatitis B receiving stable nucleos(t)ide analogue (NA) therapy.Read full original descriptionShow less
Safety and Efficacy of Sequential Treatment With a PD-1 Antibody and Pegylated Interferon-α in Nucleos(t)Ide Analogue-Suppressed Patients With Chronic Hepatitis B
This is a prospective, multicenter, randomized, open-label controlled clinical trial designed to evaluate the efficacy and safety of a sequential treatment strategy incorporating a PD-1 antibody and pegylated interferon-α (Peg-IFNα) in patients with chronic hepatitis B receiving stable nucleos(t)ide analogue (NA) therapy.
Inclusion: 1. Aged 18-55 years; 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.Patients with HBV DNA negative, HBeAg negative, HBsAg quantification ≤ 500IU/ml .
Exclusion: 4.Patients received interferon therapy within 6 months; 5.Patients received immunosuppressive therapy or other therapy influenced study within 6 months; 9.Alcohol or drug abuse/dependence; 3.History of or suspicion of hepatocellular carcinoma; 7.Hepatitis A, hepatitis C, hepatitis D, HIV infection or other active infections; 8.Presence of severe uncontrolled diseases of respiratory, cardiovascular or other organ systems; 10.Other conditions rendering subjects ineligible for enrollment, including but not limited to absolute contraindications to interferon therapy, known hypersensitivity to any study drug or their excipients, and anticipated poor compliance with treatment and follow-up procedures; 2.platelet count < 90×10\^9/L, WBC count < 3.0×10\^9/L, ALT /AST> ULN (40U/L), total bilirubin > 2ULN; 1. Cirrhosis; 6.Pregnancy.