Status:
NOT_YET_RECRUITING
A Study on Peginterferon Alfa-2b Combined With NAs in Compensated HBV Cirrhosis
Lead Sponsor:
Xiamen Humanity Hospital
Conditions:
HBV-related Liver Cirrhosis
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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 NA...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2031
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07183293
Start Date
October 1 2025
End Date
September 1 2031
Last Update
September 19 2025
Active Locations (2)
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1
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, China
2
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, China