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

Hepatitis B, Chronic Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03358108
• Other study ID #: OCEAN study
• Status: Recruiting
• Start date: February 27, 2018
• Est. completion date: December 1, 2022

Study information

• Verified date: October 2018
• Source: Tongji Hospital
• Contact: Ning Qin, Doctor
• Phone: 862783662391
• Email: qning[@]vip.sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
China	BeiJing YouAn Hospital, Capital Medical University	Beijing	Beijing
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 of Fujian Medical University	Fuzhou	Fujian
China	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu
China	The Second Hospital of Nanjing	Nanjing	Jiangsu
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	Traditional Chinese Medicine,Xiamen Hospital	Shantou	Xiamen
China	The first affiliated hospital of Wenzhou medical universtiy	Wenzhou	Zhejiang
China	Tongji Hospital	Wuhan	Hubei
China	The First Affiliated Hospital of College of Medicine, Zhejiang University	Zhejiang	Hangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Qin Ning

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of HBsAg negative at week 260	Compare the HBsAg negative rate at week 260 with that at baseline	week 260
Secondary	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
Secondary	HBsAg quantification decline from baseline to week 260	HBsAg quantification decline from baseline to week 260 are measured.	week 260
Secondary	Change from baseline in HBsAg seroconversion at week 260	HBsAg seroconversion from baseline is measured	week 260
Secondary	The rate of HBsAb positive at week 260	Compare the rate of HBsAb positive at week 260 with that at baseline	week 260
Secondary	Measure the Fibroscan value	Fibroscan value from baseline is measured	week 260
Secondary	the occurrence rate of liver cirrhosis	Statistics for occurrence rates of liver cirrhosis	week 260
Secondary	the occurrence rate of HCC related to HBV	Statistics for occurrence rates of HCC related to HBV	week 260
Secondary	The proportion of patients with HBV DNA <1000 copies / mL	Statistics the proportion of patients with HBV DNA <1000 copies / mL	week 260