A Study on Peginterferon Alfa-2b Combined With NAs in Compensated HBV Cirrhosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Peginterferon alfa-2b combined with NAs, NAs.
- Who it may be relevant to
- Registry conditions: HBV-related Liver Cirrhosis. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter, Randomized, Prospective Study on the Efficacy and Safety of Peginterferon Alfa-2b Combined With Nucleos(t)Ide Analogues in Patients With Compensated HBV-Related Liver Cirrhosis
Overview
This study is a multicenter, randomized, prospective trial designed to evaluate the efficacy and safety of pegylated interferon α-2b (Peg-IFN-α2b) combined with nucleos(t)ide analogues (NAs) versus NAs monotherapy in patients with compensated hepatitis B cirrhosis. A total of 30 patients with compensated HBV-related cirrhosis will be enrolled and randomized in a 2:1 ratio to either Experimental Group 1 (n=20) or Experimental Group 2 (n=10). The treatment regimens consist of Peg-IFN-α2b combined with NAs (ETV/TAF/TMF/TDF) or NAs (ETV/TAF/TMF/TDF) monotherapy.
Interventions
- Drug Peginterferon alfa-2b combined with NAs
Subcutaneous injection therapy,Treatment will continue for 48 weeks, with follow-up assessments conducted every 12 weeks. The dosage will be adjusted based on the patient's disease status. - Drug NAs
Treatment will continue for 48 weeks, with follow-up assessments conducted every 12 weeks. The dosage will be adjusted based on the patient's disease status.
Primary outcome measures
- Change in liver histological score from baseline [Time frame: 24 weeks after the end of treatment]
Secondary outcome measures (11)
- Incidence of hepatocellular carcinoma (HCC) [Time frame: Week 48]
- Incidence of hepatic decompensation events [Time frame: Week 48]
- Change in liver stiffness measurement (LSM) from baseline [Time frame: Week 48,24 weeks after the end of treatment]
- Change in AST-to-Platelet Ratio Index (APRI) from baseline [Time frame: Week 48,24 weeks after the end of treatment]
- Change in Fibrosis-4 Index (FIB-4) from baseline [Time frame: Week 48,24 weeks after the end of treatment]
- HBsAg loss rate [Time frame: Week 48,24 weeks after the end of treatment]
- Seroconversion rate [Time frame: Week 48,24 weeks after the end of treatment]
- HBeAg loss rate [Time frame: Week 48,24 weeks after the end of treatment]
- HBV DNA undetectability rate [Time frame: Week 48,24 weeks after the end of treatment]
- HBV RNA undetectability rate [Time frame: Week 48,24 weeks after the end of treatment]
- HBV RNA decline rate [Time frame: Week 48,24 weeks after the end of treatment]
Eligibility criteria
Inclusion criteria
- Clinical diagnosis of compensated HBV-related liver cirrhosis (Child-Pugh class A or B);
- The subject is able to understand and comply with the content, requirements, and restrictions of the protocol, is willing and able to complete the study per protocol requirements, fully understands the potential adverse reactions, and voluntarily provides written informed consent prior to study initiation;
- Aged 18 to 60 years (inclusive), any gender;
- Female subjects of childbearing potential must have a negative pregnancy test at screening;
- Subjects (including their partners) must voluntarily use effective non-drug contraception from prior to dosing until six months after discontinuation of the study drug and have no plan to donate sperm or ova; or subjects (including their partners) are of non-childbearing potential (surgically sterilized or postmenopausal).
Exclusion criteria
- Decompensated liver cirrhosis, hepatic failure, or hepatocellular carcinoma; presence of other liver diseases such as fatty liver disease, alcoholic liver disease, drug-induced liver injury, autoimmune liver disease, or Wilson's disease;
- History of clinically significant diseases of the cardiovascular, hematological and lymphatic, respiratory, urinary, endocrine, immune, psychiatric, or nervous systems (e.g., epilepsy), ophthalmic diseases, or thyroid-related disorders;
- Pregnancy, lactation, or intention to become pregnant during the study period;
- Known or suspected allergy to the investigational product(s) or any of its excipients;
- Participation in any other interventional clinical trial within 3 months prior to screening or planning to participate in another clinical trial during the study;
- Any other condition considered by the investigator to be inappropriate for participation in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Xiamen Hospital of Traditional Chinese Medicine — Xiamen
- Zhongshan Hospital Affiliated to Xiamen University — Xiamen
Identifiers
NCT: NCT07183293 · HAXM20250731