Chronic Hepatitis b
Conditions
Keywords
CHB, Peginterferon, retreatment
Brief summary
This is a real-world, prospective, multicenter, non-randomized, controlled study. It aims to investigate the efficacy and safety of pegylated interferon α-2b (PEG IFN α-2b) monotherapy versus its combination with nucleos(t)ide analogs (NAs) regarding hepatitis B surface antigen (HBsAg) clearance in interferon-experienced patients with chronic hepatitis B (CHB). Subjects will receive either interferon-based therapy or NAs monotherapy based on their personal willingness and physicians' professional recommendations, with a uniform 48-week treatment course for all enrolled patients.
Interventions
DRUGPEG IFNα-2b monotherapy or combination therapy with NAs
Peginterferon α-2b injection, 180mcg, s.c, once a week, for 48 weeks.If HBV DNA is below the lower limit of detection at baseline (highly sensitive assay is recommended), PEG IFNα-2b monotherapy will be administered.
Peginterferon α-2b injection, 180mcg, s.c, once a week, for 48 weeks.If HBV DNA is below the lower limit of detection at baseline (highly sensitive assay is recommended), PEG IFNα-2b monotherapy will be administered.
Sponsors
xieqing
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Inclusion criteria
* • Voluntary participation and ability to understand and provide written informed consent. * Age 18-65 years (inclusive), either gender. * Documented HBsAg positivity for at least 6 months, or other evidence confirming chronic hepatitis B (CHB). * Prior interferon therapy before enrollment (treatment discontinuation ≥ 3 months), with HBsAg level at the end of prior treatment reduced by ≥ 50% from baseline. * HBsAg ≤ 500 IU/mL at screening, and HBsAg rebound at screening not exceeding 50% of the baseline HBsAg level during the first-round interferon therapy. * Negative pregnancy test within 24 hours prior to the first dose (for women of childbearing potential); all subjects (male and female) must use effective contraceptive measures during the study.
Exclusion criteria
* • Pregnant or lactating women, or subjects with a pregnancy plan during the study period. * Subjects with neuropsychiatric disorders, in particular a history of depression, anxiety, mania, schizophrenia, or a family history of psychiatric disorders (especially a history of depression or depressive tendency). * Concurrent active infection with hepatitis A, hepatitis C, hepatitis E and/or HIV, or chronic liver disease due to other causes (e.g., alcoholic hepatitis, drug-induced liver injury, autoimmune liver disease, etc.). * Evidence of acute severe liver damage: e.g., ALT \> 10 × ULN, or marked ALT elevation accompanied by significant hyperbilirubinemia. * Evidence of decompensated liver disease: e.g., ascites, esophagogastric variceal bleeding, sepsis, hepatic encephalopathy, hepatorenal syndrome, etc.; or prior evidence of decompensated cirrhosis. * Evidence of hepatocellular carcinoma (HCC), or AFP \> 1 × ULN. * Renal diseases: acute or chronic nephritis, renal insufficiency, nephrotic syndrome, etc.; or serum creatinine \> 1 × ULN at screening. * Neutrophil count \< 1.5 × 10⁹/L, platelet count \< 90 × 10⁹/L, or serum phosphorus \< 0.8 mmol/L during the screening period. * Autoimmune diseases (e.g., psoriasis, systemic lupus erythematosus, etc.), endocrine disorders (e.g., thyroid diseases, diabetes, etc.), hypertension poorly controlled by prescription medications (blood pressure ≥ 140/90 mmHg), a history of severe heart disease (especially poorly controlled within 6 months), severe retinopathy or other serious ophthalmologic diseases, or other organic lesions or dysfunction of vital organs. * Subjects planning to undergo or having previously undergone organ transplantation. * Subjects with hypersensitivity to the investigational product or its excipients, or meeting any contraindication listed in the prescribing information of the investigational product. * Other conditions deemed inappropriate for enrollment by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects with undetectable HBsAg | Week 48 |
| Percentage of subjects with undetectable HBV DNA | Week 48 |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients with a decrease in HBV DNA from baseline | Week 1-48 |
| Proportion of subjects with HBV DNA below the lower limit of detection | Week 1-48 |
| Number of patients with a decrease in HBsAg from baseline | Week 1-48 |
| Proportion of HBsAg seroclearance | Week 1-48 |
| Proportion of HBsAg seroconversion | Week 1-48 |
| Proportion of HBeAg seroclearance | Week 1-48 |
| Proportion of HBeAg seroconversion | Week 1-48 |
| Serious adverse events | Week 1-48 |
Countries
China
Contacts
CONTACTQing Xie
PRINCIPAL_INVESTIGATORQing Xie
Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed