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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 : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Qin Ning, Tongji Hospital

Study Description
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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.

Condition or disease
Hepatitis B, Chronic

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 1600 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 : February 27, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. The rate of HBsAg negative at week 260 [ Time Frame: week 260 ]
    Compare the HBsAg negative rate at week 260 with that at baseline


Secondary Outcome Measures :
  1. 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

  2. HBsAg quantification decline from baseline to week 260 [ Time Frame: week 260 ]
    HBsAg quantification decline from baseline to week 260 are measured.

  3. Change from baseline in HBsAg seroconversion at week 260 [ Time Frame: week 260 ]
    HBsAg seroconversion from baseline is measured

  4. 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

  5. Measure the Fibroscan value [ Time Frame: week 260 ]
    Fibroscan value from baseline is measured

  6. the occurrence rate of liver cirrhosis [ Time Frame: week 260 ]
    Statistics for occurrence rates of liver cirrhosis

  7. the occurrence rate of HCC related to HBV [ Time Frame: week 260 ]
    Statistics for occurrence rates of HCC related to HBV

  8. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
Contact: Ning Qin, Doctor 862783662391 qning@vip.sina.com
Contact: Han Meifang, Doctor 862783662391 mfan@foxmail.com

Locations
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         
Sponsors and Collaborators
Qin Ning
Investigators
Principal Investigator: Ning Qin, Doctor Department of Infectious Diseases, Tongji Hospital
More Information
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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: October 19, 2018
Last Verified: October 2018

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