A Study on Peginterferon Alfa-2b Combined With NAs in Compensated HBV Cirrhosis

Xiamen Humanity Hospital

Status: Not yet enrolling

Conditions: HBV-related Liver Cirrhosis

Treatments: Drug: NAs; Drug: Peginterferon alfa-2b combined with NAs

Study type: Interventional

Funder types: Other

Identifiers

NCT07183293

HAXM20250731

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Group 1

Experimental group

Treatment:

Drug: Peginterferon alfa-2b combined with NAs

Group 2

Experimental group

Treatment:

Drug: NAs