NCT07809165Not yet recruiting
Sequential PD-1 Antibody and Pegylated Interferon Therapy for Nucleos(t)Ide Analogue-suppressed Chronic Hepatitis B
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
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 25 Aug 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 30 Sept 2029
- Lead sponsor
- Beijing 302 Hospital
- Diseases
- Hepatitis B
- NCT number
- NCT07809165
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Sept 2026 to the primary completion date, 30 Sept 2029
- 4 sites 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
- 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;
Other illness
- 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.
Lab values
- 2.platelet count \< 90×10\^9/L, WBC count \< 3.0×10\^9/L, ALT /AST\> ULN (40U/L), total bilirubin \> 2ULN;
Other
- 1\. Cirrhosis;
- 6.Pregnancy
Who the study is looking for
- 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 .
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shandong Public Health Clinical Center Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| The Third People's Hospital of Taiyuan Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| The Second Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| The First Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi’an | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.