Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

Efficacy and Safety of Antiviral Therapy With Peg-interferon for Chronic Hepatitis B Complicated With Nonalcoholic Fatty Liver Disease（OCEAN PROJECT）

Q: Who can participate in NCT06368882?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT06368882?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

Efficacy and Safety of Antiviral Therapy With Peg-interferon for Chronic Hepatitis B Complicated With Nonalcoholic Fatty Liver Disease（OCEAN PROJECT） (NCT06368882) is a Phase 4 interventional studying Nonalcoholic Fatty Liver Disease and Chronic Hepatitis b, sponsored by First Affiliated Hospital of Wenzhou Medical University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 1,500 participants makes this one of the larger Nonalcoholic Fatty Liver Disease trials currently registered. Trials at this scale are typically global, run across many sites, and designed to generate the definitive evidence package for an FDA approval submission or a label expansion.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age of 18-60 years old, male or female (including 18 and 60 years old); 2. meet the diagnostic criteria for chronic hepatitis B in the Guidelines for the prevention and treatment of chronic hepatitis B (2022 edition), and meet the imaging diagnostic criteria for fatty liver in the guidelines for the prevention and treatment of non-alcoholic fatty liver disease (2018 Update edition). 3. serum HBsAg positive \>6 months; 4. NAs treatment: baseline HBsAg≤1500 IU/ml, HBeAg negative, HBV DNA negative (not detected); 5. IHC initial treatment: baseline HBsAg\<1000 IU/ml, HBeAg negative, HBV DNA negative (undetectable), ALT and AST persistently normal (ULN: \<50 IU/L in men, \<40 IU/L in women); 6. a negative serum pregnancy test within 24 hours before the first dose (for women of reproductive age); 7. willing to receive treatment and signed willing to sign a consent form. Who Should NOT Join This Trial: 1. co-infection with active hepatitis A, C, D, E and/or HIV; Or combined with drug-induced liver injury, inherited metabolic liver disease, autoimmune hepatitis, alcoholic liver disease; 2. Liver tumor was detected by liver imaging at the time of screening; 3. patients diagnosed with hepatitis B cirrhosis, that is, those with liver biopsy pathology consistent with liver cirrhosis, or with two or more of the following five criteria, excluding non-cirrhotic portal hypertension: ① imaging examination showed signs of liver cirrhosis and/or portal hypertension; ② Esophagogastric varices were found by endoscopy; ③ Liver stiffness was consistent with cirrhosis; ④ Blood biochemical examination showed decreased albumin level (\< 35 g/L) and/or prolonged prothrombin time (prolonged \> 3 seconds compared with the control); ⑤ Blood routine examination showed platelet count \< 100×109/L; 4. pregnant or lactating women or those who plan to become pregnant and do not want to use contraception during the study period; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Age of 18-60 years old, male or female (including 18 and 60 years old); 2. meet the diagnostic criteria for chronic hepatitis B in the Guidelines for the prevention and treatment of chronic hepatitis B (2022 edition), and meet the imaging diagnostic criteria for fatty liver in the guidelines for the prevention and treatment of non-alcoholic fatty liver disease (2018 Update edition). 3. serum HBsAg positive \>6 months; 4. NAs treatment: baseline HBsAg≤1500 IU/ml, HBeAg negative, HBV DNA negative (not detected); 5. IHC initial treatment: baseline HBsAg\<1000 IU/ml, HBeAg negative, HBV DNA negative (undetectable), ALT and AST persistently normal (ULN: \<50 IU/L in men, \<40 IU/L in women); 6. a negative serum pregnancy test within 24 hours before the first dose (for women of reproductive age); 7. willing to receive treatment and signed informed consent. Exclusion Criteria: 1. co-infection with active hepatitis A, C, D, E and/or HIV; Or combined with drug-induced liver injury, inherited metabolic liver disease, autoimmune hepatitis, alcoholic liver disease; 2. Liver tumor was detected by liver imaging at the time of screening; 3. patients diagnosed with hepatitis B cirrhosis, that is, those with liver biopsy pathology consistent with liver cirrhosis, or with two or more of the following five criteria, excluding non-cirrhotic portal hypertension: ① imaging examination showed signs of liver cirrhosis and/or portal hypertension; ② Esophagogastric varices were found by endoscopy; ③ Liver stiffness was consistent with cirrhosis; ④ Blood biochemical examination showed decreased albumin level (\< 35 g/L) and/or prolonged prothrombin time (prolonged \> 3 seconds compared with the control); ⑤ Blood routine examination showed platelet count \< 100×109/L; 4. pregnant or lactating women or those who plan to become pregnant and do not want to use contraception during the study period; 5. neutrophil count \<1.5×109/L or platelet count \<90×109/L. Patients with creatinine higher than 1.5 times the upper limit of normal; 6. The patients and their close relatives (parents, siblings, etc.) had a history of severe mental illness, especially depression. Severe psychosis is defined as severe depression or psychosis, suicide attempt, hospitalization due to psychosis, or a period of incapacitation due to psychosis; 7. patients with a history of immune-mediated diseases (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis) or abnormally elevated levels of autoimmune antibodies; 8. patients with serious diseases of heart, lung, kidney, brain, blood and other important organs, and patients with other malignant tumors; 9. history of severe epilepsy or current use of antiepileptic drugs. Control of unstable diabetes, hypertension, thyroid disease, etc. A history of severe retinopathy or other evidence of retinopathy; 10. any history of organ transplantation and existing functional graft (except corneal or hair transplantation); 11. patients who are allergic to interferon and its drug components, and who are not suitable for interferon according to the investigator's judgment; 12. Patients deemed by the investigator to be ineligible for the study.

Treatments Being Tested

DRUG

Peg-Interferon α

Peg IFN-α injection was subcutaneously injected 180 μg weekly on the first day of the first week, and NAs was administered daily according to the standard dosage of each drug. For example, HBsAg sero-conversion is achieved within 48 weeks of treatment, Peg IFNα combined with NAs or PEG-IFNα monotherapy was continued for 12 weeks, with a maximum of 96 weeks, and follow-up up to 240 weeks after treatment. If HBsAg negative sero-conversion is not achieved within 48 weeks of treatment, the maximum duration of PEG-IFNα is not more than 96 weeks. If Peg IFNα combined NAs regimen is used, NAs can be continued until the drug can be ended (if HBsAg negative conversion is achieved, NAs should be ended after consolidation therapy not less than 24 weeks; if HBsAg negative conversion is not achieved, NAS should be continued), followed up to 240 weeks after treatment.

Locations (5)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Ningbo No.2 Hospital

Ningbo, China

Ruian People's Hospital

Rui’an, China

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Wenzhou People's Hospital

Wenzhou, China

Yueqing People's Hospital

Yueqing, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06368882), the sponsor (First Affiliated Hospital of Wenzhou Medical University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06368882 clinical trial studying?

Who can participate in NCT06368882?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06368882?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06368882. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06368882. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.