Sustained HBsAg and Viral Response in Patients Achieved HBsAg Loss by Interferon Treatment
Study Details
Study Description
Brief Summary
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).
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- The rate of sustained HBsAg negativity and viral response in 96 weeks [From the enrollment to 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
Secondary Outcome Measures
- The rate of sustained HBsAg negativity and viral response in long term [From the enrollment to 240 weeks]
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
- The rate of sustained HBsAg negativity and viral response in subset analysis in 96 weeks [From the enrollment to 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
- The rate of sustained HBsAg negativity and viral response in subset analysis for long term [From the enrollment to 240 weeks]
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
- Predictor(s) for recurrence of HBsAg positivity or detectable levels of HBV DNA in 96 weeks [From the enrollment to 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.
- Predictor(s) for recurrence of HBsAg positivity or detectable levels of HBV DNA in long term [From the enrollment to 240 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 240.
Other Outcome Measures
- Exploratory outcomes on complication rates of liver cancer and decompensated cirrhosis in 96 weeks [from the enrollment to the 96 weeks]
Percentage of patient who have clinical cirrhosis or liver cancer during the observational period
- Exploratory outcomes on complication rates of liver cancer and decompensated cirrhosis in 240 weeks [from the enrollment to the 240 weeks]
Percentage of patient who have clinical cirrhosis or liver cancer during the observational period
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients who had chronic hepatitis B and achieved HBsAg loss by interferon treatment.
Exclusion Criteria:
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Active consumption of alcohol and/or drugs
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Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
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History of autoimmune hepatitis
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Psychiatric disease
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Evidence of neoplastic diseases of the liver
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Ditan Hospital,Capital Medical University | Beijing | Beijing | China | 100015 |
Sponsors and Collaborators
- Beijing Ditan Hospital
Investigators
- Principal Investigator: Yao Xie, MD, Beijing Ditan Hospital, Beijing, China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DTXY002