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A Study on Peginterferon Alfa-2b Combined With NAs in Compensated HBV Cirrhosis | Clinical Trials | Clareo Health

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

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

NCT07183293•Xiamen Humanity Hospital

View on ClinicalTrials.gov

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

Age

18 - 60 years

Sex

ALL

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.

Locations (2)

Xiamen Hospital of Traditional Chinese Medicine

Xiamen, China

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, China

Key Dates

Start Date

October 1, 2025

Primary Completion Date

March 1, 2027

Completion Date

September 1, 2031

Last Updated

September 19, 2025

Enrollment

ESTIMATED participants

Conditions

HBV-related Liver Cirrhosis

Interventions

Peginterferon alfa-2b combined with NAs

DRUG

NAs

DRUG

Contacts

Wenqi Huang

CONTACT

18965179823 huangwenqi@haxm.com

Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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