Clinical trial NCT03358108: A Prospective,Observational Follow-up Study of Nucleoside Treated Patients With Chronic Hepatitis B (OCEAN Study)
Official title: A Prospective, Multicentre Observational Follow-up Study of PegIFN Treatment Sustained Response in Nucleoside Experienced Patients With Chronic Hepatitis B (the OCEAN Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis B, Chronic
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The rate of HBsAg negative at week 260
timeFrame: week 260
Secondary outcomes:
measure: The maintenance response rate of HBsAg negativity at week 260
timeFrame: week 260
measure: HBsAg quantification decline from baseline to week 260
timeFrame: week 260
measure: Change from baseline in HBsAg seroconversion at week 260
timeFrame: week 260
measure: The rate of HBsAb positive at week 260
timeFrame: week 260
measure: Measure the Fibroscan value
timeFrame: week 260
measure: the occurrence rate of liver cirrhosis
timeFrame: week 260
measure: the occurrence rate of HCC related to HBV
timeFrame: week 260
measure: The proportion of patients with HBV DNA <1000 copies / mL
timeFrame: week 260
Other outcomes:
Locations:
city: Beijing
country: China
facility: BeiJing YouAn Hospital, Capital Medical University
state: Beijing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Zhejiang
country: China
facility: The First Affiliated Hospital of College of Medicine, Zhejiang University
state: Hangzhou
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
city: Changsha
country: China
facility: Departmen of infectious disease, Xiangya Hospital, Central-south Universit
state: Hunan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: The Second Hospital of Nanjing
state: Jiangsu
city: Shantou
country: China
facility: Traditional Chinese Medicine,Xiamen Hospital
state: Xiamen
city: Wenzhou
country: China
facility: The first affiliated hospital of Wenzhou medical universtiy
state: Zhejiang
Study officials:
affiliation: Department of Infectious Diseases, Tongji Hospital
name: Ning Qin, Doctor
role: PRINCIPAL_INVESTIGATOR
References: