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

NCT ID: NCT03358108

Last Updated: 2018-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-27

Study Completion Date

2022-12-01

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.

Conditions

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Hepatitis B, Chronic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A: interferon group

formerly interferon group (including interferon alone or interferon combined with other drugs)

No interventions assigned to this group

Group B:nucleoside analogue group

formerly nucleoside analogue treatment group. Each group was followed for five years

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Male and female patients from 18 to 65 years of age;
2. Have finished the OSST,COST,Endeavor, Anchor,NPGV studies;
3. Agree to participate in the study and sign the patient informed consent.

Exclusion Criteria

1. patients have not participated in the OSST,Cost,Endeavor,Anchor or NPGV study ;
2. unable or unwilling to provide informed consent or follow the research requirements
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qin Ning

OTHER

Sponsor Role lead

Responsible Party

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Qin Ning

Director and Chair of Department of Infectious Diseases

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ning Qin, Doctor

Role: PRINCIPAL_INVESTIGATOR

Department of Infectious Diseases, Tongji Hospital

Locations

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BeiJing YouAn Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Site Status RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Site Status RECRUITING

The First Affiliated Hospital of College of Medicine, Zhejiang University

Zhejiang, Hangzhou, China

Site Status RECRUITING

Tongji Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Departmen of infectious disease, Xiangya Hospital, Central-south Universit

Changsha, Hunan, China

Site Status RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status RECRUITING

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Site Status RECRUITING

The Second Hospital of Nanjing

Nanjing, Jiangsu, China

Site Status RECRUITING

Traditional Chinese Medicine,Xiamen Hospital

Shantou, Xiamen, China

Site Status RECRUITING

The first affiliated hospital of Wenzhou medical universtiy

Wenzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ning Qin, Doctor

Role: CONTACT

862783662391

Han Meifang, Doctor

Role: CONTACT

862783662391

Facility Contacts

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Chen Xinyue, Doctor

Role: primary

Jiang Jiaji, Doctor

Role: primary

Qi Xia

Role: primary

Qin Ning, Ph.D. M.D.

Role: primary

86 27 83662391

Meifang Han, Ph.D. M.D.

Role: backup

86 27 83662391

Tan Deming, Doctor

Role: primary

Chen Yongping, Doctor

Role: primary

Other Identifiers

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OCEAN study

Identifier Type: -

Identifier Source: org_study_id

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