ClinicalTrials.gov
ClinicalTrials.gov Menu

A Prospective,Observational Follow-up Study of Nucleoside Treated Patients With Chronic Hepatitis B (OCEAN Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

November 20, 2017
November 30, 2017
October 19, 2018
February 27, 2018
December 1, 2020   (Final data collection date for primary outcome measure)
The rate of HBsAg negative at week 260 [ Time Frame: week 260 ]
Compare the HBsAg negative rate at week 260 with that at baseline
Same as current
Complete list of historical versions of study NCT03358108 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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.
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.
Observational
Observational Model: Case-Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
Hepatitis B, Chronic
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1600
647
December 1, 2022
December 1, 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact: Ning Qin, Doctor 862783662391 qning@vip.sina.com
Contact: Han Meifang, Doctor 862783662391 mfan@foxmail.com
China
 
 
NCT03358108
OCEAN study
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Qin Ning, Tongji Hospital
Qin Ning
Not Provided
Principal Investigator: Ning Qin, Doctor Department of Infectious Diseases, Tongji Hospital
Tongji Hospital
October 2018