HBV-related Liver CirrhosisNCT07183293
A Study on Peginterferon Alfa-2b Combined With NAs in Compensated HBV Cirrhosis
A study testing Peginterferon alfa-2b combined with NAs and NAs in people with HBV-related Liver Cirrhosis, run by Xiamen Humanity Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HBV-related Liver Cirrhosis
- What is being tested?
- Peginterferon alfa-2b combined with NAs and NAs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- Oct 2025to Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Xiamen Hospital of Traditional Chinese Medicine
Xiamen
Hong Cai
Zhongshan Hospital Affiliated to Xiamen University
Xiamen
Ligang Chen
About this study
Official 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
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
- Being tested
- Peginterferon alfa-2b combined with NAs, NAs
- Keywords
- Peginterferon α-2b
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Drug: Peginterferon alfa-2b combined with NAs |
| Group 2 | Experimental | Not described Receives: Drug: NAs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in liver histological score from baseline
Measured: 24 weeks after the end of treatment
Secondary outcomes (11)
Incidence of hepatocellular carcinoma (HCC)
Measured: Week 48
Incidence of hepatic decompensation events
Measured: Week 48
Change in liver stiffness measurement (LSM) from baseline
Evaluation is performed using liver imaging data such as liver MRI and histopathological data.
Measured: Week 48,24 weeks after the end of treatment
Change in AST-to-Platelet Ratio Index (APRI) from baseline
Measured: Week 48,24 weeks after the end of treatment
Change in Fibrosis-4 Index (FIB-4) from baseline
Measured: Week 48,24 weeks after the end of treatment
HBsAg loss rate
Measured: Week 48,24 weeks after the end of treatment
Seroconversion rate
Measured: Week 48,24 weeks after the end of treatment
HBeAg loss rate
Measured: Week 48,24 weeks after the end of treatment
HBV DNA undetectability rate
Measured: Week 48,24 weeks after the end of treatment
HBV RNA undetectability rate
Measured: Week 48,24 weeks after the end of treatment
HBV RNA decline rate
Measured: Week 48,24 weeks after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study startOct 2025 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBV-related Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiamen Humanity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenqi Huang, Xiamen Humanity Hospital
- Investigators
- Wenqi Huang, Principal investigator, Xiamen Humanity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183293
- Sponsor's protocol ID
- HAXM20250731
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07183293
- Acronym / sponsor ID
- HAXM20250731
- Conditions
- HBV-related Liver Cirrhosis
- Keywords
- Peginterferon α-2b
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xiamen Humanity HospitalUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Peginterferon alfa-2b combined with NAs |
| Group 2 | Experimental | Drug: NAs |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peginterferon alfa-2b combined with NAsSubcutaneous 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. | Drug | Group 1 |
| NAsTreatment 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. | Drug | Group 2 |
Primary outcome
Change in liver histological score from baseline
Time frame: 24 weeks after the end of treatment
11 secondary outcomes
Incidence of hepatocellular carcinoma (HCC)
Time frame: Week 48
Incidence of hepatic decompensation events
Time frame: Week 48
Change in liver stiffness measurement (LSM) from baseline
Time frame: Week 48,24 weeks after the end of treatment
Change in AST-to-Platelet Ratio Index (APRI) from baseline
Time frame: Week 48,24 weeks after the end of treatment
Change in Fibrosis-4 Index (FIB-4) from baseline
Time frame: Week 48,24 weeks after the end of treatment
HBsAg loss rate
Time frame: Week 48,24 weeks after the end of treatment
Seroconversion rate
Time frame: Week 48,24 weeks after the end of treatment
HBeAg loss rate
Time frame: Week 48,24 weeks after the end of treatment
HBV DNA undetectability rate
Time frame: Week 48,24 weeks after the end of treatment
HBV RNA undetectability rate
Time frame: Week 48,24 weeks after the end of treatment
HBV RNA decline rate
Time frame: Week 48,24 weeks after the end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wenqi Huang principal investigator
Xiamen Humanity Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peginterferon alfa-2b combined with NAs and NAs in people with HBV-related Liver Cirrhosis, run by Xiamen Humanity Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenqi Huang (18965179823, huangwenqi@haxm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in liver histological score from baseline (time frame: 24 weeks after the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.