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)

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.

Study Overview

• Status: Unknown
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 1600

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Youan Hospital, Capital Medical University
      • Contact: Chen Xinyue, Doctor
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • The First Affiliated Hospital of Fujian Medical University
      • Contact: Jiang Jiaji, Doctor
  • Guangxi
    • Nanning, Guangxi, China
      • Recruiting
      • The First Affiliated Hospital of Guangxi Medical University
  • Hangzhou
    • Zhejiang, Hangzhou, China, Doctor
      • Recruiting
      • The First Affiliated Hospital of College of Medicine, Zhejiang University
      • Contact: Qi Xia
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital
      • Contact: Qin Ning, Ph.D. M.D.; Phone Number: 86 27 83662391; Email: qning@vip.sina.com
      • Contact: Meifang Han, Ph.D. M.D.; Phone Number: 86 27 83662391; Email: hanmeifang@hotmail.com
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Departmen of infectious disease, Xiangya Hospital, Central-south Universit
      • Contact: Tan Deming, Doctor
    • Changsha, Hunan, China
      • Recruiting
      • The Second Xiangya Hospital of Central South University
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • The First Affiliated Hospital with Nanjing Medical University
    • Nanjing, Jiangsu, China
      • Recruiting
      • The Second Hospital of Nanjing
  • Xiamen
    • Shantou, Xiamen, China
      • Recruiting
      • Traditional Chinese Medicine,Xiamen Hospital
  • Zhejiang
    • Wenzhou, Zhejiang, China
      • Recruiting
      • The first affiliated hospital of Wenzhou medical universtiy
      • Contact: Chen Yongping, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of HBsAg negative at week 260	Compare the HBsAg negative rate at week 260 with that at baseline	week 260

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The maintenance response rate of HBsAg negativity at week 260	the proportion of patients with sustained HBsAg negativity at week 260 among the patients whose HBsAg negative at baseline	week 260
HBsAg quantification decline from baseline to week 260	HBsAg quantification decline from baseline to week 260 are measured.	week 260
Change from baseline in HBsAg seroconversion at week 260	HBsAg seroconversion from baseline is measured	week 260
The rate of HBsAb positive at week 260	Compare the rate of HBsAb positive at week 260 with that at baseline	week 260
Measure the Fibroscan value	Fibroscan value from baseline is measured	week 260
the occurrence rate of liver cirrhosis	Statistics for occurrence rates of liver cirrhosis	week 260
the occurrence rate of HCC related to HBV	Statistics for occurrence rates of HCC related to HBV	week 260
The proportion of patients with HBV DNA <1000 copies / mL	Statistics the proportion of patients with HBV DNA <1000 copies / mL	week 260

Collaborators and Investigators

• Sponsor: Qin Ning
• Investigators: Principal Investigator: Ning Qin, Doctor, Department of Infectious Diseases, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2018
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: November 29, 2017
• First Posted (Actual): November 30, 2017

Study Record Updates

• Last Update Posted (Actual): October 19, 2018
• Last Update Submitted That Met QC Criteria: October 18, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic
• Other Study ID Numbers: OCEAN study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No