Chronic Hepatitis BNCT06357806
The Treatment of PD-1 Antibody Combined With Peg-IFNα in NAs-suppressed CHB Patients
A study testing Sintilimab, Peg-IFNα-2b and NAs in people with Chronic Hepatitis B, run by Beijing 302 Hospital at 1 site in China.
Trial summary
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. 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, Peg-IFNα-2b and NAs
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 17 May 2024to 8 Oct 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Cirrhosis;
- 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;
- History of or suspicion of hepatocellular carcinoma
- Patients received interferon therapy within 12 months;
- Patients received immunosuppressive therapy or other therapy influenced study within 12 months;
- Hepatitis A, hepatitis C, hepatitis D, HIV infection or other active infections;
- Alcohol or drug abuse/dependence;
- Investigator judges that the participants are not suitable for this study.
Trial locations and contacts
1 site in 1 country.
China1 site
the Fifth Medical Center, Chinese PLA General Hospital
Beijing, Beijing Municipality, 100039
About this study
Official title: 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
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.
- Conditions
- Chronic Hepatitis B
- Being tested
- Sintilimab, Peg-IFNα-2b, NAs
- 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
Peg-IFNα-2bDrug
180ug/0.5ml/1bottle
NAsDrug
Also called ETV/TDF/TAF
tablets
| Study group | Role | What they receive |
|---|---|---|
| Peg-IFNα group | Active comparator | 180 ug Peg-IFNα-2b subcutaneous injection once/week for 48 weeks NAs Receives: Drug: Peg-IFNα-2b; Drug: NAs |
| PD-1 antibody group | Active comparator | 1.5 mg/kg Sintilimab intravenous injection once per 3 weeks for 24 weeks NAs Receives: Drug: Sintilimab; Drug: NAs |
| PD-1 antibody combined Peg-IFNα group | Experimental | 1.5 mg/kg Sintilimab intravenous injection once per 3 weeks for 24 weeks 180 ug Peg-IFNα-2b subcutaneous injection once/week for 48 weeks NAs |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of HBsAg loss at 24 weeks and 48 weeks.
Evaluate the level of HBsAg 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 at 24 weeks and 48 weeks.
Measured: 48 weeks
The rate of HBsAb positive at 24 weeks and 48 weeks.
Evaluate the level of serum HBsAb at 24 weeks and 48 weeks.
Measured: 48 weeks
The concentration of HBcrAg at baseline, 12 weeks, 24 weeks and 48 weeks.
Evaluate the level of serum HBcrAg at baseline, 12 weeks, 24 weeks and 48 weeks.
Measured: 48 weeks
The concentration of pgRNA at baseline, 12 weeks, 24 weeks and 48 weeks.
Evaluate the level of serum pgRNA at baseline, 12 weeks, 24 weeks and 48 weeks.
Measured: 48 weeks
The concentration of anti-HBc at baseline, 12 weeks, 24 weeks and 48 weeks.
Evaluate the level of serum anti-HBc 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 posted10 Apr 2024
- Study start17 May 2024
- Primary completion8 Oct 2026 (estimated)
- Study completion8 Oct 2026 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 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
- NCT06357806
- Sponsor's protocol ID
- PIN-CHB-1
- Status last verified
- Oct 2025
- First submitted
- 20 Mar 2024
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang H, Li X, Lu J, Zhang X, Dang S, Li Y, He Y, Guo Y, Wang J, Maimaitijiang W, Zheng S, Ren S, Cao H, Zhang W, Zhang X, Ma H, Wang FS, Fu J. Safety and efficacy of PD-1 antibody combined with pegylated interferon alpha for functional cure in nucleos(t)ide analogues-suppressed chronic hepatitis B patients: protocol for a multicentre randomised controlled trial. BMJ Open. 2025 Sep 21;15(9):e105710. doi: 10.1136/bmjopen-2025-105710.
PubMed 40976664
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06357806
- Acronym / sponsor ID
- PIN-CHB-1
- Conditions
- Chronic Hepatitis B
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- 17 May 2024 (actual)
- Primary completion
- 8 Oct 2026 (estimated)
- Study completion
- 8 Oct 2026 (estimated)
- First posted
- 10 Apr 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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Peg-IFNα group | Active comparator | Drug: Peg-IFNα-2b, Drug: NAs180 ug Peg-IFNα-2b subcutaneous injection once/week for 48 weeks NAs |
| PD-1 antibody group | Active comparator | Drug: Sintilimab, Drug: NAs1.5 mg/kg Sintilimab intravenous injection once per 3 weeks for 24 weeks NAs |
| PD-1 antibody combined Peg-IFNα group | Experimental | –1.5 mg/kg Sintilimab intravenous injection once per 3 weeks for 24 weeks 180 ug Peg-IFNα-2b subcutaneous injection once/week for 48 weeks NAs |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- Cirrhosis;
- 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;
- History of or suspicion of hepatocellular carcinoma
- Patients received interferon therapy within 12 months;
- Patients received immunosuppressive therapy or other therapy influenced study within 12 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 |
|---|---|---|
| Sintilimab100mg/10ml/1bottle | Drug | PD-1 antibody group |
| Peg-IFNα-2b180ug/0.5ml/1bottle | Drug | Peg-IFNα group |
| NAsAlso: ETV/TDF/TAFtablets | Drug | PD-1 antibody group, Peg-IFNα group |
Primary outcome
The rate of HBsAg loss at 24 weeks and 48 weeks.
Time frame: 48 weeks
Evaluate the level of HBsAg 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 at 24 weeks and 48 weeks.
Time frame: 48 weeks
The concentration of HBcrAg at baseline, 12 weeks, 24 weeks and 48 weeks.
Time frame: 48 weeks
The concentration of pgRNA at baseline, 12 weeks, 24 weeks and 48 weeks.
Time frame: 48 weeks
The concentration of anti-HBc 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
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 18 Mar 2026.
- Derived from this study: PubMed 40976664Wang H, Li X, Lu J, Zhang X, Dang S, Li Y, He Y, Guo Y, Wang J, Maimaitijiang W, Zheng S, Ren S, Cao H, Zhang W, Zhang X, Ma H, Wang FS, Fu J. Safety and efficacy of PD-1 antibody combined with pegylated interferon alpha for functional cure in nucleos(t)ide analogues-suppressed chronic hepatitis B patients: protocol for a multicentre randomised controlled trial. BMJ Open. 2025 Sep 21;15(9):e105710. doi: 10.1136/bmjopen-2025-105710.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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, Peg-IFNα-2b and NAs 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 5 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2026. 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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of HBsAg loss 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 NCT06357806, 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 18 Mar 2026.