An observational study in Hepatitis B, Chronic, sponsored by Qin Ning. Status unknown at 11 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-10-19.
Sponsored by Qin Ning · Observational
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.
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.
Exclusion Criteria:
formerly interferon group (including interferon alone or interferon combined with other drugs)
formerly nucleoside analogue treatment group. Each group was followed for five years
The rate of HBsAg negative at week 260
Compare the HBsAg negative rate at week 260 with that at baseline
Time frame: week 260
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
Time frame: week 260
HBsAg quantification decline from baseline to week 260
HBsAg quantification decline from baseline to week 260 are measured.
Time frame: week 260
Change from baseline in HBsAg seroconversion at week 260
HBsAg seroconversion from baseline is measured
Time frame: week 260
The rate of HBsAb positive at week 260
Compare the rate of HBsAb positive at week 260 with that at baseline
Time frame: week 260
Measure the Fibroscan value
Fibroscan value from baseline is measured
Time frame: week 260
the occurrence rate of liver cirrhosis
Statistics for occurrence rates of liver cirrhosis
Time frame: week 260
the occurrence rate of HCC related to HBV
Statistics for occurrence rates of HCC related to HBV
Time frame: week 260
The proportion of patients with HBV DNA <1000 copies / mL
Statistics the proportion of patients with HBV DNA \<1000 copies / mL
Time frame: week 260
This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Qin Ning