An observational study in Chronic Hepatitis B, sponsored by Beijing Ditan Hospital. Status unknown at 1 site in China. Open to participants aged 2 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-11-14.
Sponsored by Beijing Ditan Hospital · Observational
Chronic hepatitis B (CHB) is a serious liver disease worldwide, and the leading cause of cirrhosis and hepatocellular carcinoma (HCC).HBsAg loss/seroconversion is considered to be the ideal endpoint of antiviral therapy in both HBeAg-positive and HBeAg-negative patients, as well as the ultimate treatment goal in CHB. However, some patients who have achieved HBsAg loss would reverse back to HBsAg positive, or even become HBV reactive with recurrence of viremia. In current study, the viral and HBsAg response in patients who have achieved HBsAg loss by interferon (IFN) treatment will be observed for 96 weeks after the completion of IFN treatment. The primary analysis will be performed at the end of 96 weeks. Following the completion of the study period of 96 weeks, patients will be offered to participate in a long term study for further observation of additional 144 weeks (total of 240 weeks from the enrollment).
Chronic hepatitis B patients who have achieved HBsAg loss from interferon treatment will be enrolled and observed for 96 weeks. Serum HBV DNA, HBsAg, anti-HBs, HBeAg, and anti-HBe will be measured every 3 months during the observation period. Their liver function and chemistry tests are also performed every 3 months. The liver ultrasonic examination would be taken every 3-6 months. The primary measurement is the percentage of patients who have positive HBsAg and/or a detectable level of HBV DNA. Following the completion of the study period, patients will be offered to participate in a long term study for further observation of additional 144 weeks.
1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.
This study's enrollment of 420 is close to the median of 390 across 407 observational studies indexed under Hepatitis B.
Browse Hepatitis B studies →Beijing Ditan Hospital is the lead sponsor of 52 studies on the registry; 2 are open to participants now.
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The study population in this study is composed of patients who have chronic hepatitis B and achieved HBsAg loss from interferon treatment. Eligible patients will have serum HBsAg and HBV DNA tests every 3 months for 96 weeks after finishing the interferon treatment. The sustained HBsAg response is defined as the levels of serum HBsAg mantaining below the low level of quantitation and the levels of HBV DNA remain undetectable. Following the completion of the study period, patients will be offered to participate in a long term study for further observation up to 240 weeks.
Exclusion Criteria:
The rate of sustained HBsAg negativity and viral response in 96 weeks
The percentage of patients who have both undetectable level of HBsAg and undetectable level of serum HBV DNA at 96 weeks after completing treatment with interferon
Time frame: From the enrollment to 96 weeks
The rate of sustained HBsAg negativity and viral response in long term
The percentage of patients who have both undetectable level of HBsAg and undetectable level of serum HBV DNA at 240 weeks after completing treatment with interferon
Time frame: From the enrollment to 240 weeks
The rate of sustained HBsAg negativity and viral response in subset analysis in 96 weeks
The percentage of patients who have both undetectable level of HBsAg and undetectable level of serum HBV DNA at 96 weeks after completing treatment with interferon mono-therapy versus those who have the same endpoints after the completion of the interferon therapy in the combination or sequencing of oral antiviral therapy
Time frame: From the enrollment to 96 weeks
The rate of sustained HBsAg negativity and viral response in subset analysis for long term
The percentage of patients who have both undetectable level of HBsAg and undetectable level of serum HBV DNA at 240 weeks after completing treatment with interferon mono-therapy versus those who have the same endpoints after completing the interferon therapy in the combination or sequencing of oral antiviral therapy
Time frame: From the enrollment to 240 weeks
Predictor(s) for recurrence of HBsAg positivity or detectable levels of HBV DNA in 96 weeks
Clinical features and baseline factors will be analyzed by comparing patients who have sustained HBsAg negativity and viral response vs. those who have no sustained endpoints at week 96.
Time frame: From the enrollment to 96 weeks
Predictor(s) for recurrence of HBsAg positivity or detectable levels of HBV DNA in long term
Clinical features and baseline factors will be analyzed by comparing patients who have sustained HBsAg negativity and viral response vs. those who have no sustained endpoints at week 240.
Time frame: From the enrollment to 240 weeks
Exploratory outcomes on complication rates of liver cancer and decompensated cirrhosis in 96 weeks
Percentage of patient who have clinical cirrhosis or liver cancer during the observational period
Time frame: from the enrollment to the 96 weeks
Exploratory outcomes on complication rates of liver cancer and decompensated cirrhosis in 240 weeks
Percentage of patient who have clinical cirrhosis or liver cancer during the observational period
Time frame: from the enrollment to the 240 weeks
This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Beijing Ditan Hospital