A Prospective,Observational Follow-up Study of Nucleoside Treated Patients With Chronic Hepatitis B (OCEAN Study)
A Prospective, Multicentre Observational Follow-up Study of PegIFN Treatment Sustained Response in Nucleoside Experienced Patients With Chronic Hepatitis B (the OCEAN Study)
1 other identifier
observational
1,600
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2018
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2017
CompletedFirst Posted
Study publicly available on registry
November 30, 2017
CompletedStudy Start
First participant enrolled
February 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedOctober 19, 2018
October 1, 2018
2.8 years
November 20, 2017
October 18, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
The rate of HBsAg negative at week 260
Compare the HBsAg negative rate at week 260 with that at baseline
week 260
Secondary Outcomes (8)
The maintenance response rate of HBsAg negativity at week 260
week 260
HBsAg quantification decline from baseline to week 260
week 260
Change from baseline in HBsAg seroconversion at week 260
week 260
The rate of HBsAb positive at week 260
week 260
Measure the Fibroscan value
week 260
- +3 more secondary outcomes
Study Arms (2)
Group A: interferon group
formerly interferon group (including interferon alone or interferon combined with other drugs)
Group B:nucleoside analogue group
formerly nucleoside analogue treatment group. Each group was followed for five years
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Qin Ninglead
Study Sites (11)
BeiJing YouAn Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Zhejiang, Hangzhou, Doctor, China
Tongji Hospital
Wuhan, Hubei, 430030, China
Departmen of infectious disease, Xiangya Hospital, Central-south Universit
Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
The Second Hospital of Nanjing
Nanjing, Jiangsu, China
Traditional Chinese Medicine,Xiamen Hospital
Shantou, Xiamen, China
The first affiliated hospital of Wenzhou medical universtiy
Wenzhou, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ning Qin, Doctor
Department of Infectious Diseases, Tongji Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director and Chair of Department of Infectious Diseases
Study Record Dates
First Submitted
November 20, 2017
First Posted
November 30, 2017
Study Start
February 27, 2018
Primary Completion
December 1, 2020
Study Completion
December 1, 2022
Last Updated
October 19, 2018
Record last verified: 2018-10