A Prospective,Observational Follow-up Study of Nucleoside Treated Patients With Chronic Hepatitis B (OCEAN Study)

Study Overview
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Brief Summary
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This is a prospective, multicentre observational follow-up study of PegIFN treatment unstained response in nucleoside experienced patients with Chronic Hepatitis B.Patients will join this study after finished following clinical trail about A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With HBeAg Positive Chronic Hepatitis B(OSST trail),A Real-World Study of Pegylated Interferon In Nucleoside-treated Patients With Chronic Hepatitis B (COST study), Combination Therapy With Interferon Plus Interleukin 2 and Hepatitis B Vaccine in Chronic Hepatitis B Patients(Endeavor study),A Prospective Clinical Trial in Chronic Hepatitis B Patients Nucleotide Analogues Experienced (Anchor A Study),Sequential/Combination Therapy in Nucleoside or Nucleotide Analogue (NA)-Suppressed Chronic Hepatitis B Patients (NPGV study).We plan to compare the HBsAg negative rate and maintenance rate,the occurrence of liver cirrhosis and the occurrence rate of hepatocellular carcinoma(HCC) related to hepatitis B virus(HBV) within five years between interferon group (including interferon alone or interferon combined with other drugs) and nucleoside analogues.Patients were divided into two groups based on whether they received interferon or not.

Detailed Description
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Patients who treated with nucleoside analogs, and previously took part in the OSST,COST,Endeavor, Anchor NPGV studies, were included in the observational study after they finished. The patients entered the following two observation groups based on previous studies: Group A: formerly interferon group (including interferon alone or interferon combined with other drugs); Group B: formerly nucleoside analogue treatment group. Each group was followed for five years.All patients were followed up for physical examination (vital signs, whole body examination) and laboratory assessment (HBsAg quantification, HBeAg quantification, HBV DNA, HBV immunology marker, blood routine, blood biochemistry, alpha fetoprotein, Fibroscan, liver Doppler) in every six month.

Official Title
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A Prospective, Multicentre Observational Follow-up Study of PegIFN Treatment Sustained Response in Nucleoside Experienced Patients With Chronic Hepatitis B (the OCEAN Study)

Conditions
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Hepatitis B, Chronic

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients from 18 to 65 years of age; Have finished the OSST,COST,Endeavor, Anchor,NPGV studies; Agree to participate in the study and sign the patient informed consent. Exclusion Criteria: patients have not participated in the OSST,Cost,Endeavor,Anchor or NPGV study ; unable or unwilling to provide informed consent or follow the research requirements

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A: interferon group<br>formerly interferon group (including interferon alone or interferon combined with other drugs) | |
| Group B:nucleoside analogue group<br>formerly nucleoside analogue treatment group. Each group was followed for five years | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of HBsAg negative at week 260 | Compare the HBsAg negative rate at week 260 with that at baseline | week 260 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The maintenance response rate of HBsAg negativity at week 260 | the proportion of patients with sustained HBsAg negativity at week 260 among the patients whose HBsAg negative at baseline | week 260 | 
| HBsAg quantification decline from baseline to week 260 | HBsAg quantification decline from baseline to week 260 are measured. | week 260 | 
| Change from baseline in HBsAg seroconversion at week 260 | HBsAg seroconversion from baseline is measured | week 260 | 
| The rate of HBsAb positive at week 260 | Compare the rate of HBsAb positive at week 260 with that at baseline | week 260 | 
| Measure the Fibroscan value | Fibroscan value from baseline is measured | week 260 | 
| the occurrence rate of liver cirrhosis | Statistics for occurrence rates of liver cirrhosis | week 260 | 
| the occurrence rate of HCC related to HBV | Statistics for occurrence rates of HCC related to HBV | week 260 | 
| The proportion of patients with HBV DNA <1000 copies / mL | Statistics the proportion of patients with HBV DNA <1000 copies / mL | week 260 |