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NCT Number: NCT07183293

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xiamen Hospital of Traditional Chinese Medicine, Xiamen, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Peginterferon alfa-2b combined with NAs

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.

NAs

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.

Primary outcomes

  1. Change in liver histological score from baseline

    Time frame: 24 weeks after the end of treatment

Secondary outcomes

  1. Incidence of hepatocellular carcinoma (HCC)

    Time frame: Week 48

  2. Incidence of hepatic decompensation events

    Time frame: Week 48

  3. Change in liver stiffness measurement (LSM) from baseline

    Time frame: Week 48,24 weeks after the end of treatment

    Evaluation is performed using liver imaging data such as liver MRI and histopathological data.

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

    Time frame: Week 48,24 weeks after the end of treatment

  5. Change in Fibrosis-4 Index (FIB-4) from baseline

    Time frame: Week 48,24 weeks after the end of treatment

  6. HBsAg loss rate

    Time frame: Week 48,24 weeks after the end of treatment

  7. Seroconversion rate

    Time frame: Week 48,24 weeks after the end of treatment

  8. HBeAg loss rate

    Time frame: Week 48,24 weeks after the end of treatment

  9. HBV DNA undetectability rate

    Time frame: Week 48,24 weeks after the end of treatment

  10. HBV RNA undetectability rate

    Time frame: Week 48,24 weeks after the end of treatment

  11. HBV RNA decline rate

    Time frame: Week 48,24 weeks after the end of treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Wenqi Huang

CONTACT

[email protected]

18965179823

Sponsors and collaborators

Lead sponsor

Xiamen Humanity Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2031
First posted
Sep 19, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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