Actively Recruiting
Efficacy and Safety of Antiviral Therapy With Peg-interferon for Chronic Hepatitis B Complicated With Nonalcoholic Fatty Liver Disease（OCEAN PROJECT）
Led by First Affiliated Hospital of Wenzhou Medical University · Updated on 2024-04-16
1500
Participants Needed
5
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, multicenter, open-label, non-randomized controlled real-world study to explore the efficacy and safety and to accumulate more evidence-based medical data of an antiviral treatment programme for chronic viral hepatitis B with nonalcoholic fatty liver disease. A total of 1500 patients with chronic hepatitis B complicated with nonalcoholic fatty liver disease are divided into test group (1000 patients receiving PEG-IFNα-based antiviral therapy (combined NAs or Peg-IFNα monotherapy) and control group（500 patients receiving NAs monotherapy） according to their treatment intention. Laboratory and medical data from specified follow-up points are collected, and adverse events and drug combinations are recorded detailly. The primary efficacy indicator is HBsAg clearance at 48 weeks of treatment, and the secondary indicators included: (1) HBsAg clearance at 96 weeks of treatment, (2) Cumulative HBsAg clearance at week 24、120、144、168、192、216 and 240; (3) The improvement of liver function level(ALT, AST, TBIL, etc.), blood lipid (TC, TG, LDL-C, HDL-C, etc.), fasting blood glucose, insulin resistance index (HOMA-IR), controlled attenuation parameter, body mass index , liver stiffness measurement, liver histological fibrosis, FIB-4 index from baseline; (4)Incidence of liver cirrhosis and hepatocellular carcinoma during follow-up. The security assessment includes adverse events, vital signs, and imaging.
CONDITIONS
Official Title
Efficacy and Safety of Antiviral Therapy With Peg-interferon for Chronic Hepatitis B Complicated With Nonalcoholic Fatty Liver Disease（OCEAN PROJECT）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 60 years, male or female
- Diagnosed with chronic hepatitis B according to 2022 guidelines
- Diagnosed with fatty liver by imaging per 2018 non-alcoholic fatty liver disease guidelines
- Positive serum HBsAg for more than 6 months
- For NAs treatment: baseline HBsAg ≤1500 IU/ml, HBeAg negative, HBV DNA undetectable
- For initial Peg-IFN treatment: baseline HBsAg <1000 IU/ml, HBeAg negative, HBV DNA undetectable, ALT and AST persistently normal
- Negative serum pregnancy test within 24 hours before first dose for women of reproductive age
- Willing to receive treatment and provide informed consent
You will not qualify if you...
- Co-infection with active hepatitis A, C, D, E, or HIV; drug-induced liver injury; inherited metabolic liver disease; autoimmune hepatitis; alcoholic liver disease
- Detectable liver tumor on imaging at screening
- Diagnosed hepatitis B cirrhosis or meeting criteria for cirrhosis (imaging signs, varices, liver stiffness, low albumin or prolonged prothrombin time, low platelet count)
- Pregnant, lactating, or planning pregnancy without contraception during study
- Neutrophil count <1.5×10⁹/L or platelet count <90×10⁹/L; creatinine >1.5 times upper normal limit
- History of severe mental illness, especially depression or psychosis
- History of immune-mediated diseases or elevated autoimmune antibodies
- Serious diseases of heart, lung, kidney, brain, blood, or other organs; other malignancies
- History of severe epilepsy or current antiepileptic drug use; uncontrolled diabetes, hypertension, thyroid disease; severe retinopathy
- History of organ transplantation with functional graft (except corneal or hair)
- Allergy to interferon or its components; deemed unsuitable for interferon by investigator
- Investigator judgment of ineligibility for the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Ningbo No.2 Hospital
Ningbo, China
Actively Recruiting
2
Ruian People's Hospital
Rui’an, China
Actively Recruiting
3
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Actively Recruiting
4
Wenzhou People's Hospital
Wenzhou, China
Actively Recruiting
5
Yueqing People's Hospital
Yueqing, China
Actively Recruiting
Research Team
Y
Yongping Chen, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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