A Prospective, Multicentre Observational Follow-up Study of PegIFN Treatment Sustained Response in Nucleoside Experienced Patients With Chronic Hepatitis B (the OCEAN Study)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,600
- 试验地点
- 11
- 主要终点
- The rate of HBsAg negative at week 260
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
The rate of HBsAg negative at week 260
时间窗: week 260
Compare the HBsAg negative rate at week 260 with that at baseline
次要结局
- Change from baseline in HBsAg seroconversion at week 260(week 260)
- The proportion of patients with HBV DNA <1000 copies / mL(week 260)
- The maintenance response rate of HBsAg negativity at week 260(week 260)
- HBsAg quantification decline from baseline to week 260(week 260)
- The rate of HBsAb positive at week 260(week 260)
- Measure the Fibroscan value(week 260)
- the occurrence rate of liver cirrhosis(week 260)
- the occurrence rate of HCC related to HBV(week 260)
研究者
Qin Ning
Director and Chair of Department of Infectious Diseases
Tongji Hospital