Chronic Hepatitis BNCT06457477
Sequential Combination Therapy With PD-1 Antibody and Peg-IFNα in CHB Patients
A study testing Sintilimab, NAs and Peg-IFNα-2b in people with Chronic Hepatitis B, run by Beijing 302 Hospital at 1 site in China.
Trial summary
This is a prospective study to evaluate the safety and efficacy of Sintilimab (PD-1 antibody) in sequential combination with Peg-IFNα-2b in NA-supressed CHB patients who had previously received Peg-IFNα therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Sintilimab, NAs and Peg-IFNα-2b
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2024to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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. In virologically suppressed (HBV DNA below the lower detection limit) CHB patients by NAs treatment, HBsAg decreased by less than 0.5log in the last 6 months of Peg-IFNα therapy, and then discontinued Peg-IFNα at least 6 months;
- 4.Patients with HBV DNA negative, HBeAg negative, HBsAg quantification ≤ 200IU/ml at Peg-IFNα discontinuation and enrollment.
Who cannot join
- 1. Cirrhosis;
- 2.platelet count < 90×109/L, WBC count < 3.0×109/L, neutrophil count < 1.3×109/L, ALT > ULN (40U/L), total bilirubin > 2ULN;
- 3.History of or suspicion of hepatocellular carcinoma
- 4.Patients received immunosuppressive therapy or other therapy influenced study within 12 months;
- 5.Hepatitis A, hepatitis C, hepatitis D, HIV infection or other active infections;
- 6.Alcohol or drug abuse/dependence;
- 7.Investigator judges that the participants are not suitable for this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Fifth Medical Center, Chinese PLA General Hospital
Beijing, Beijing Municipality
Junliang Fu, 86-10-66933214, fjunliang@163.com
Fu-Sheng Wang, +861066933328, fswang302@163.com
About this study
Official title: The Safety and Efficacy of Sequential Combination Therapy With PD-1 Antibody and Pegylated Interferon-α in NA-supressed Chronic Hepatitis B Patients
This is a prospective study to evaluate the safety and efficacy of Sintilimab (PD-1 antibody) in sequential combination with Peg-IFNα-2b in NA-supressed CHB patients who had previously received Peg-IFNα therapy.
- Conditions
- Chronic Hepatitis B
- Being tested
- Sintilimab, NAs, Peg-IFNα-2b
- 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
100mg/10ml/1bottle
NAsDrug
Also called ETV/TDF/TAF
tablets
Peg-IFNα-2bDrug
180ug/0.5ml/1bottle
| Study group | Role | What they receive |
|---|---|---|
| PD-1 antibody therapy | Experimental | Not described Receives: Drug: Sintilimab; Drug: NAs; Drug: Peg-IFNα-2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of HBsAg loss (<0.05 IU/ml) at 24 weeks and 48 weeks
Evaluate the level of HBsAg (IU/ml) at 24 weeks and 48 weeks.
Measured: 48 weeks
Incidence of treatment-emergent adverse events/serious adverse events
Evaluate the treatment-emergent adverse events/serious adverse events
Measured: 48 weeks
Secondary outcomes (6)
The rate of HBsAg decline > 1log(IU/ml) at 24 weeks and 48 weeks
Evaluate the level of serum HBsAg (IU/ml) at 24 weeks and 48 weeks.
Measured: 48 weeks
The rate of HBsAb positive (>10 IU/ml) at 24 weeks and 48 weeks.
The rate of HBsAb positive (>10 IU/ml) at 24 weeks and 48 weeks.
Measured: 48 weeks
The concentration of HBcrAg (logU/mL) at baseline, 12 weeks, 24 weeks and 48 weeks
Evaluate the level of serum HBcrAg (logU/mL) at baseline, 12 weeks, 24 weeks and 48 weeks.
Measured: 48 weeks
The concentration of pgRNA (>10 IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks
Evaluate the level of serum pgRNA (>10 IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks
Measured: 48 weeks
The concentration of anti-HBc (IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks
Evaluate the level of serum anti-HBc (IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks
Measured: 48 weeks
Immune response of T cell, B cell, NK cell at baseline, 12 weeks, 24 weeks and 48 weeks
Evaluate the frequency and function of T cell, B cell, NK cell (tested by flowcytometry/fluorospot/elispot)
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 posted13 Jun 2024
- Study start15 Jun 2024 (estimated)
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457477
- Sponsor's protocol ID
- PIN-CHB-2
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang H, Zhang C, Li X, Li Y, Zhang X, Xu R, Wang K, Lv S, Fan X, Wang Q, Liu S, Yang S, Zhang X, Dang S, Wang FS, Fu J. Sequential combination of anti-PD-1 antibody and PEG-IFNalpha in chronic hepatitis B patients: correlates of HBsAg loss with enhanced T-cell responses. Emerg Microbes Infect. 2026 Dec;15(1):2735154. doi: 10.1080/22221751.2026.2735154. Epub 2026 Sep 25.
PubMed 42789423
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Sequential Combination Therapy With PD-1 Antibody and Pegylated Interferon-α in NA-supressed Chronic Hepatitis B Patients
- ClinicalTrials.gov ID
- NCT06457477
- Acronym / sponsor ID
- PIN-CHB-2
- Conditions
- Chronic Hepatitis B
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 13 Jun 2024 (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 study to evaluate the safety and efficacy of Sintilimab (PD-1 antibody) in sequential combination with Peg-IFNα-2b in NA-supressed CHB patients who had previously received Peg-IFNα therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD-1 antibody therapy | Experimental | Drug: Sintilimab, Drug: NAs, Drug: Peg-IFNα-2b |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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. In virologically suppressed (HBV DNA below the lower detection limit) CHB patients by NAs treatment, HBsAg decreased by less than 0.5log in the last 6 months of Peg-IFNα therapy, and then discontinued Peg-IFNα at least 6 months;
- 4.Patients with HBV DNA negative, HBeAg negative, HBsAg quantification ≤ 200IU/ml at Peg-IFNα discontinuation and enrollment.
Key exclusion criteria (7 listed)
- 1. Cirrhosis;
- 2.platelet count < 90×109/L, WBC count < 3.0×109/L, neutrophil count < 1.3×109/L, ALT > ULN (40U/L), total bilirubin > 2ULN;
- 3.History of or suspicion of hepatocellular carcinoma
- 4.Patients received immunosuppressive therapy or other therapy influenced study within 12 months;
- 5.Hepatitis A, hepatitis C, hepatitis D, HIV infection or other active infections;
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 |
|---|---|---|
| Sintilimab100mg/10ml/1bottle | Drug | PD-1 antibody therapy |
| NAsAlso: ETV/TDF/TAFtablets | Drug | PD-1 antibody therapy |
| Peg-IFNα-2b180ug/0.5ml/1bottle | Drug | PD-1 antibody therapy |
Primary outcome
The rate of HBsAg loss (<0.05 IU/ml) at 24 weeks and 48 weeks
Time frame: 48 weeks
Evaluate the level of HBsAg (IU/ml) at 24 weeks and 48 weeks.
Incidence of treatment-emergent adverse events/serious adverse events
Time frame: 48 weeks
Evaluate the treatment-emergent adverse events/serious adverse events
6 secondary outcomes
The rate of HBsAg decline > 1log(IU/ml) at 24 weeks and 48 weeks
Time frame: 48 weeks
The rate of HBsAb positive (>10 IU/ml) at 24 weeks and 48 weeks.
Time frame: 48 weeks
The concentration of HBcrAg (logU/mL) at baseline, 12 weeks, 24 weeks and 48 weeks
Time frame: 48 weeks
The concentration of pgRNA (>10 IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks
Time frame: 48 weeks
The concentration of anti-HBc (IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks
Time frame: 48 weeks
Immune response of T cell, B cell, NK cell at baseline, 12 weeks, 24 weeks and 48 weeks
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Derived from this study: PubMed 42789423Wang H, Zhang C, Li X, Li Y, Zhang X, Xu R, Wang K, Lv S, Fan X, Wang Q, Liu S, Yang S, Zhang X, Dang S, Wang FS, Fu J. Sequential combination of anti-PD-1 antibody and PEG-IFNalpha in chronic hepatitis B patients: correlates of HBsAg loss with enhanced T-cell responses. Emerg Microbes Infect. 2026 Dec;15(1):2735154. doi: 10.1080/22221751.2026.2735154. Epub 2026 Sep 25.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sintilimab, NAs and Peg-IFNα-2b in people with Chronic Hepatitis B, run by Beijing 302 Hospital at 1 site 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 7 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: status not confirmed, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of HBsAg loss (<0.05 IU/ml) at 24 weeks and 48 weeks (time frame: 48 weeks). 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?
On the ClinicalTrials.gov record for NCT06457477, which also lists 1 linked publication.
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 20 Jun 2024.