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

NCT06368882 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2024-04-16

No results posted yet for this study

Summary

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

Interventions

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.

Sponsors & Collaborators

  • First Affiliated Hospital of Wenzhou Medical University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06368882 on ClinicalTrials.gov