Sintilimab
DrugSintilimab 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.
NCT Number: NCT07809165
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.
Trial opening soon.
Get Notified18 year–55 year
All sexes
Interventional
Not applicable
Shandong Public Health Clinical Center, Jinan, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: ETV, TDF, TAF
Time frame: 48weeks
Time frame: 48weeks
Time frame: 48 weeks
Time frame: 48 weeks
Time frame: 48 weeks
Evaluate the level of serum HBcrAg at baseline, at weeks 12,24 and 48.
Time frame: 48 weeks
Evaluate the level of serum pgRNA at baseline, at weeks 12,24 and 48.
Time frame: 48 weeks
Evaluate the level of serum anti-HBc at baseline, at weeks 12,24 and 48.
Time frame: 48 weeks
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
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
The frequency (unit: percentage of peripheral lymphocytes) and function of peripheral NK-lymphocytes will be evaluated using flow cytometry.
Trial opening soon.
Get NotifiedBeijing 302 Hospital
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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