An interventional study of Sintilimab and Pegylated Interferon-α 2b in Chronic Hepatitis B, sponsored by Beijing 302 Hospital. Not yet recruiting at 4 sites in China. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Beijing 302 Hospital · Not applicable, Interventional, and Treatment
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.
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.
895 studies on the registry are indexed under Hepatitis B, Chronic; 151 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 659 interventional studies indexed under Hepatitis B, Chronic.
Browse Hepatitis B, Chronic studies →Beijing 302 Hospital is the lead sponsor of 88 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Sintilimab · Drug: Pegylated Interferon-α 2b · Drug: Nucleos(t)ide Analogues
Participants will receive Peg-IFNα in combination with continued background nucleos(t)ide analogue therapy from baseline through Week 48.
Drug: Pegylated Interferon-α 2b · Drug: Nucleos(t)ide Analogues
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.
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.
Background nucleos(t)ide analogue therapy with entecavir, tenofovir disoproxil fumarate, or tenofovir alafenamide will be continued throughout the study.
Also known as: ETV, TDF, TAF
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.
Background nucleos(t)ide analogue therapy with entecavir, tenofovir disoproxil fumarate, or tenofovir alafenamide will be continued throughout the study.
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
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.
Evaluate the level of serum 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.
Evaluate the level of serum 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.
Evaluate the level of serum 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.
The frequency (unit: percentage of peripheral lymphocytes) and function of peripheral T-lymphocytes will be evaluated using flow cytometry, FluoroSpot, and ELISpot assays.
Time frame: 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.
Time frame: 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.
Time frame: 48 weeks
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2029, 36 months later.
Of 42 interventional studies with no phase under Hepatitis B, Chronic, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 121. This study's planned 36 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Sintilimab
Beijing 302 Hospital