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.
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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria:
1. Clinical diagnosis of compensated HBV-related liver cirrhosis (Child-Pugh class A or B);
2. 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;
3. Aged 18 to 60 years (inclusive), any gender;
4. Female subjects of childbearing potential must have a negative pregnancy test at screening;
5. 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:
1. 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;
2. 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;
3. Pregnancy, lactation, or intention to become pregnant during the study period;
4. Known or suspected allergy to the investigational product(s) or any of its excipients;
5. Participation in any other interventional clinical trial within 3 months prior to screening or planning to participate in another clinical trial during the study;
6. Any other condition considered by the investigator to be inappropriate for participation in the study.
Primary outcome measure(s)
Change in liver histological score from baseline — 24 weeks after the end of treatment
Trial sites (2)
Facility
City
Region
Status
Xiamen Hospital of Traditional Chinese Medicine
Xiamen
China
Zhongshan Hospital Affiliated to Xiamen University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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