A Prospective,Observational Follow-up Study of Nucleoside Treated Patients With Chronic Hepatitis B (OCEAN Study)
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ClinicalTrials.gov Identifier: NCT03358108 |
Recruitment Status
:
Recruiting
First Posted
: November 30, 2017
Last Update Posted
: November 30, 2017
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Condition or disease |
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Hepatitis B, Chronic |
Study Type : | Observational |
Estimated Enrollment : | 647 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
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) |
Actual Study Start Date : | November 1, 2017 |
Estimated Primary Completion Date : | December 1, 2020 |
Estimated Study Completion Date : | December 1, 2022 |
Group/Cohort |
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Group A: interferon group
formerly interferon group (including interferon alone or interferon combined with other drugs)
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Group B:nucleoside analogue group
formerly nucleoside analogue treatment group. Each group was followed for five years
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- The rate of HBsAg negative at week 260 [ Time Frame: week 260 ]Compare the HBsAg negative rate at week 260 with that at baseline
- The maintenance response rate of HBsAg negativity at week 260 [ Time Frame: week 260 ]the proportion of patients with sustained HBsAg negativity at week 260 among the patients whose HBsAg negative at baseline
- HBsAg quantification decline from baseline to week 260 [ Time Frame: week 260 ]HBsAg quantification decline from baseline to week 260 are measured.
- Change from baseline in HBsAg seroconversion at week 260 [ Time Frame: week 260 ]HBsAg seroconversion from baseline is measured
- The rate of HBsAb positive at week 260 [ Time Frame: week 260 ]Compare the rate of HBsAb positive at week 260 with that at baseline
- Measure the Fibroscan value [ Time Frame: week 260 ]Fibroscan value from baseline is measured
- the occurrence rate of liver cirrhosis [ Time Frame: week 260 ]Statistics for occurrence rates of liver cirrhosis
- the occurrence rate of HCC related to HBV [ Time Frame: week 260 ]Statistics for occurrence rates of HCC related to HBV
- The proportion of patients with HBV DNA <1000 copies / mL [ Time Frame: week 260 ]Statistics the proportion of patients with HBV DNA <1000 copies / mL

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358108
Contact: Ning Qin, Doctor | 862783662391 | qning@vip.sina.com | |
Contact: Han Meifang, Doctor | 862783662391 | mfan@foxmail.com |
China, Beijing | |
BeiJing YouAn Hospital, Capital Medical University | Recruiting |
Beijing, Beijing, China | |
Contact: Chen Xinyue, Doctor | |
China, Fujian | |
The First Affiliated Hospital of Fujian Medical University | Recruiting |
Fuzhou, Fujian, China | |
Contact: Jiang Jiaji, Doctor | |
China, Guangxi | |
The First Affiliated Hospital of Guangxi Medical University | Recruiting |
Nanning, Guangxi, China | |
China, Hangzhou | |
The First Affiliated Hospital of College of Medicine, Zhejiang University | Recruiting |
Zhejiang, Hangzhou, China, Doctor | |
Contact: Qi Xia | |
China, Hubei | |
Tongji Hospital | Recruiting |
Wuhan, Hubei, China, 430030 | |
Contact: Qin Ning, Ph.D. M.D. 86 27 83662391 qning@vip.sina.com | |
Contact: Meifang Han, Ph.D. M.D. 86 27 83662391 hanmeifang@hotmail.com | |
China, Hunan | |
Departmen of infectious disease, Xiangya Hospital, Central-south Universit | Recruiting |
Changsha, Hunan, China | |
Contact: Tan Deming, Doctor | |
The Second Xiangya Hospital of Central South University | Recruiting |
Changsha, Hunan, China | |
China, Jiangsu | |
The First Affiliated Hospital with Nanjing Medical University | Recruiting |
Nanjing, Jiangsu, China | |
The Second Hospital of Nanjing | Recruiting |
Nanjing, Jiangsu, China | |
China, Xiamen | |
Traditional Chinese Medicine,Xiamen Hospital | Recruiting |
Shantou, Xiamen, China | |
China, Zhejiang | |
The first affiliated hospital of Wenzhou medical universtiy | Recruiting |
Wenzhou, Zhejiang, China | |
Contact: Chen Yongping, Doctor |
Principal Investigator: | Ning Qin, Doctor | Department of Infectious Diseases, Tongji Hospital |
Responsible Party: | Qin Ning, Director and Chair of Department of Infectious Diseases, Tongji Hospital |
ClinicalTrials.gov Identifier: | NCT03358108 History of Changes |
Other Study ID Numbers: |
OCEAN study |
First Posted: | November 30, 2017 Key Record Dates |
Last Update Posted: | November 30, 2017 |
Last Verified: | November 2017 |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis B Hepatitis B, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases |
Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Interferons Antineoplastic Agents Antiviral Agents Anti-Infective Agents |