Chronic Hepatitis BNCT07809165
Sequential PD-1 Antibody and Pegylated Interferon Therapy for Nucleos(t)Ide Analogue-suppressed Chronic Hepatitis B
A study testing Sintilimab, Pegylated Interferon-α 2b and Nucleos(t)ide Analogues in people with Chronic Hepatitis B, run by Beijing 302 Hospital at 4 sites in China.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Sintilimab, Pegylated Interferon-α 2b and Nucleos(t)ide Analogues
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesChina
- Study dates
- Sep 2026to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 .
Who cannot join
- 1. Cirrhosis;
- 2.platelet count < 90×10^9/L, WBC count < 3.0×10^9/L, ALT /AST> ULN (40U/L), total bilirubin > 2ULN;
- 3.History of or suspicion of hepatocellular carcinoma
- 4.Patients received interferon therapy within 6 months;
- 5.Patients received immunosuppressive therapy or other therapy influenced study within 6 months;
- 6.Pregnancy
Show all 10Show fewer
- 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;
- 9.Alcohol or drug abuse/dependence;
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
Shandong Public Health Clinical Center
Jinan
Xiaoying Li
The Third People's Hospital of Taiyuan
Taiyuan
Ying Guo
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Tianyan Chen
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Mei Li
About this study
Official title: 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.
Read the detailed description
A total of 60 participants will be randomly assigned in a 1:1 ratio to an experimental group or a control group. Participants in the experimental group will initially receive a PD-1 antibody in combination with continued NA therapy, followed by a period of triple therapy with the PD-1 antibody, Peg-IFNα, and NAs. The PD-1 antibody will then be discontinued, while Peg-IFNα plus NAs will be continued through Week 48. Participants in the control group will receive Peg-IFNα plus continued NA therapy from baseline through Week 48.
- Conditions
- Chronic Hepatitis B
- Being tested
- Sintilimab, Pegylated Interferon-α 2b, Nucleos(t)ide Analogues
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Sintilimab will be administered intravenously at a dose of 1.0 mg/kg at Weeks 0, 6, 12, and 18, for a total of four doses.
Pegylated Interferon-α 2bDrug
Peg-IFNα will be administered subcutaneously once weekly from Week 12 through Week 48.
Dose: 135 μg or 180 μg, according to the study protocol. When sintilimab and Peg-IFNα are scheduled during the same treatment period, administration of the two drugs will be separated by at least 72 hours.
Nucleos(t)ide AnaloguesDrug
Also called ETV, TDF, TAF
Background nucleos(t)ide analogue therapy with entecavir, tenofovir disoproxil fumarate, or tenofovir alafenamide will be continued throughout the study.
Pegylated Interferon-α 2bDrug
Peg-IFNα will be administered subcutaneously once weekly from Week 0 through Week 48.
Dose: 135 μg or 180 μg, according to the study protocol.
Nucleos(t)ide AnaloguesDrug
Background nucleos(t)ide analogue therapy with entecavir, tenofovir disoproxil fumarate, or tenofovir alafenamide will be continued throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Sequential PD-1 Antibody and Peg-IFNα | Experimental | Participants will continue background nucleos(t)ide analogue therapy throughout the study. During Weeks 0-12, participants will receive the PD-1 antibody plus NAs. Peg-IFNα will be added at Week 12, resulting in triple therapy with the PD-1 antibody, Peg-IFNα, and NAs during Weeks 12-24. After completion of PD-1 antibody treatment at Week 24, participants will continue Peg-IFNα plus NAs through Week 48. Receives: Drug: Sintilimab; Drug: Pegylated Interferon-α 2b; Drug: Nucleos(t)ide Analogues |
| Peg-IFNα | Active comparator | Participants will receive Peg-IFNα in combination with continued background nucleos(t)ide analogue therapy from baseline through Week 48. Receives: Drug: Pegylated Interferon-α 2b; Drug: Nucleos(t)ide Analogues |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of patients with HBsAg loss at Weeks 24 and 48
Measured: 48weeks
Incidence of treatment-emergent adverse events/serious adverse events
Measured: 48weeks
Secondary outcomes (8)
The rate of patients with HBsAg decline > 1log(IU/ml) at Weeks 24 and 48
Measured: 48 weeks
The rate of patients with HBsAb positive at Weeks 24 and 48.
Measured: 48 weeks
The concentration of HBcrAg at baseline, at weeks 12, 24 and 48.
Evaluate the level of serum HBcrAg at baseline, at weeks 12,24 and 48.
Measured: 48 weeks
The concentration of pgRNA at baseline, at weeks 12,24 and 48.
Evaluate the level of serum pgRNA at baseline, at weeks 12,24 and 48.
Measured: 48 weeks
The concentration of anti-HBc at baseline, at weeks 12,24 and 48.
Evaluate the level of serum anti-HBc at baseline, at weeks 12,24 and 48.
Measured: 48 weeks
Frequency and function of peripheral T-lymphocytes assessed by flow cytometry, FluoroSpot and ELISpot, at weeks 12,24 and 48.
The frequency (unit: percentage of peripheral lymphocytes) and function of peripheral T-lymphocytes will be evaluated using flow cytometry, FluoroSpot, and ELISpot assays.
Measured: 48 weeks
Frequency and function of peripheral B-lymphocytes assessed by flow cytometry, FluoroSpot and ELISpot,at weeks 12,24 and 48.
The frequency (unit: percentage of peripheral lymphocytes) and function of peripheral B-lymphocytes will be evaluated using flow cytometry, FluoroSpot, and ELISpot assays.
Measured: 48 Weeks
Frequency and function of peripheral NK-lymphocytes assessed by flow cytometry, FluoroSpot and ELISpot at weeks 12,24 and 48.
The frequency (unit: percentage of peripheral lymphocytes) and function of peripheral NK-lymphocytes will be evaluated using flow cytometry.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junliang Fu, Principal investigator, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809165
- Sponsor's protocol ID
- KY-2026-7-122-2
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07809165
- Acronym / sponsor ID
- KY-2026-7-122-2
- Conditions
- Chronic Hepatitis B
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A total of 60 participants will be randomly assigned in a 1:1 ratio to an experimental group or a control group. Participants in the experimental group will initially receive a PD-1 antibody in combination with continued NA therapy, followed by a period of triple therapy with the PD-1 antibody, Peg-IFNα, and NAs. The PD-1 antibody will then be discontinued, while Peg-IFNα plus NAs will be continued through Week 48. Participants in the control group will receive Peg-IFNα plus continued NA therapy from baseline through Week 48.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequential PD-1 Antibody and Peg-IFNα | Experimental | Drug: Sintilimab, Drug: Pegylated Interferon-α 2b, Drug: Nucleos(t)ide AnaloguesParticipants will continue background nucleos(t)ide analogue therapy throughout the study. During Weeks 0-12, participants will receive the PD-1 antibody plus NAs. Peg-IFNα will be added at Week 12, resulting in triple therapy with the PD-1 antibody, Peg-IFNα, and NAs during Weeks 12-24. After completion of PD-1 antibody treatment at Week 24, participants will continue Peg-IFNα plus NAs through Week 48. |
| Peg-IFNα | Active comparator | Drug: Pegylated Interferon-α 2b, Drug: Nucleos(t)ide AnaloguesParticipants will receive Peg-IFNα in combination with continued background nucleos(t)ide analogue therapy from baseline through Week 48. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 .
Key exclusion criteria (10 listed)
- 1. Cirrhosis;
- 2.platelet count < 90×10^9/L, WBC count < 3.0×10^9/L, ALT /AST> ULN (40U/L), total bilirubin > 2ULN;
- 3.History of or suspicion of hepatocellular carcinoma
- 4.Patients received interferon therapy within 6 months;
- 5.Patients received immunosuppressive therapy or other therapy influenced study within 6 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SintilimabSintilimab will be administered intravenously at a dose of 1.0 mg/kg at Weeks 0, 6, 12, and 18, for a total of four doses. | Drug | Sequential PD-1 Antibody and Peg-IFNα |
| Pegylated Interferon-α 2bPeg-IFNα will be administered subcutaneously once weekly from Week 12 through Week 48. Dose: 135 μg or 180 μg, according to the study protocol. When sintilimab and Peg-IFNα are scheduled during the same treatment period, administration of the two drugs will be separated by at least 72 hours. | Drug | Sequential PD-1 Antibody and Peg-IFNα |
| Nucleos(t)ide AnaloguesAlso: ETV, TDF, TAFBackground nucleos(t)ide analogue therapy with entecavir, tenofovir disoproxil fumarate, or tenofovir alafenamide will be continued throughout the study. | Drug | Sequential PD-1 Antibody and Peg-IFNα |
| Pegylated Interferon-α 2bPeg-IFNα will be administered subcutaneously once weekly from Week 0 through Week 48. Dose: 135 μg or 180 μg, according to the study protocol. | Drug | Peg-IFNα |
| Nucleos(t)ide AnaloguesBackground nucleos(t)ide analogue therapy with entecavir, tenofovir disoproxil fumarate, or tenofovir alafenamide will be continued throughout the study. | Drug | Peg-IFNα |
Primary outcome
The rate of patients with HBsAg loss at Weeks 24 and 48
Time frame: 48weeks
Incidence of treatment-emergent adverse events/serious adverse events
Time frame: 48weeks
8 secondary outcomes
The rate of patients with HBsAg decline > 1log(IU/ml) at Weeks 24 and 48
Time frame: 48 weeks
The rate of patients with HBsAb positive at Weeks 24 and 48.
Time frame: 48 weeks
The concentration of HBcrAg at baseline, at weeks 12, 24 and 48.
Time frame: 48 weeks
The concentration of pgRNA at baseline, at weeks 12,24 and 48.
Time frame: 48 weeks
The concentration of anti-HBc at baseline, at weeks 12,24 and 48.
Time frame: 48 weeks
Frequency and function of peripheral T-lymphocytes assessed by flow cytometry, FluoroSpot and ELISpot, at weeks 12,24 and 48.
Time frame: 48 weeks
Frequency and function of peripheral B-lymphocytes assessed by flow cytometry, FluoroSpot and ELISpot,at weeks 12,24 and 48.
Time frame: 48 Weeks
Frequency and function of peripheral NK-lymphocytes assessed by flow cytometry, FluoroSpot and ELISpot at weeks 12,24 and 48.
Time frame: 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Junliang Fu principal investigator
Beijing 302 Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sintilimab, Pegylated Interferon-α 2b and Nucleos(t)ide Analogues in people with Chronic Hepatitis B, run by Beijing 302 Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junliang Fu (86-10-66933214, fjunliang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of patients with HBsAg loss at Weeks 24 and 48 (time frame: 48weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.