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

NCT ID: NCT07183293

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2031-09-30

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 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.

Conditions

HBV-related Liver Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

Group Type: EXPERIMENTAL

Peginterferon alfa-2b combined with NAs

Intervention Type: DRUG

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.

Group 2

Group Type: EXPERIMENTAL

NAs

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiamen Humanity Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wenqi Huang

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wenqi Huang

Role: PRINCIPAL_INVESTIGATOR

Xiamen Humanity Hospital

Locations

Xiamen Hospital of Traditional Chinese Medicine

Xiamen, , China

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, , China

Countries

China

Central Contacts

Wenqi Huang

Role: CONTACT

huangwenqi@haxm.com

18965179823

Facility Contacts

Hong Cai

Role: primary

Ligang Chen

Role: primary

Other Identifiers

HAXM20250731

Identifier Type: -

Identifier Source: org_study_id