HBV-related Liver Cirrhosis
Conditions
Keywords
Peginterferon α-2b
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.
Interventions
DRUGPeginterferon 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.
DRUGNAs
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.
Sponsors
Xiamen Humanity Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in liver histological score from baseline | 24 weeks after the end of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hepatic decompensation events | Week 48 | — |
| Change in liver stiffness measurement (LSM) from baseline | Week 48,24 weeks after the end of treatment | Evaluation is performed using liver imaging data such as liver MRI and histopathological data. |
| 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 | — |
| HBsAg loss rate | Week 48,24 weeks after the end of treatment | — |
| Incidence of hepatocellular carcinoma (HCC) | Week 48 | — |
| HBeAg loss rate | Week 48,24 weeks after the end of treatment | — |
| HBV DNA undetectability rate | Week 48,24 weeks after the end of treatment | — |
| HBV RNA undetectability rate | Week 48,24 weeks after the end of treatment | — |
| HBV RNA decline rate | Week 48,24 weeks after the end of treatment | — |
| Seroconversion rate | Week 48,24 weeks after the end of treatment | — |
Countries
China
Contacts
Primary ContactWenqi Huang
Outcome results
None listed