NCT07183293

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
65mo left

Started Oct 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Oct 2025Sep 2031

First Submitted

Initial submission to the registry

September 11, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2031

Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

1.4 years

First QC Date

September 11, 2025

Last Update Submit

September 17, 2025

Conditions

HBV-related Liver Cirrhosis

Keywords

Peginterferon α-2b

Outcome Measures

Primary Outcomes (1)

  • Change in liver histological score from baseline

    24 weeks after the end of treatment

Secondary Outcomes (11)

  • Incidence of hepatocellular carcinoma (HCC)

    Week 48

  • Incidence of hepatic decompensation events

    Week 48

  • Change in liver stiffness measurement (LSM) from baseline

    Week 48,24 weeks after the end of treatment

  • Change in AST-to-Platelet Ratio Index (APRI) from baseline

    Week 48,24 weeks after the end of treatment

  • Change in Fibrosis-4 Index (FIB-4) from baseline

    Week 48,24 weeks after the end of treatment

  • +6 more secondary outcomes

Study Arms (2)

Group 1

EXPERIMENTAL
Drug: Peginterferon alfa-2b combined with NAs

Group 2

EXPERIMENTAL
Drug: NAs

Interventions

Peginterferon alfa-2b combined with NAsDRUG

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 1
NAsDRUG

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

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Xiamen Hospital of Traditional Chinese Medicine

Xiamen, China

Location

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, China

Location

MeSH Terms

Interventions

nas

Study Officials

  • Wenqi Huang

    Xiamen Humanity Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenqi Huang

CONTACT

18965179823huangwenqi@haxm.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

September 11, 2025

First Posted

September 19, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

September 1, 2031

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)