Clinical trial NCT02336399: Sustained HBsAg and Viral Response in Patients Achieved HBsAg Loss by Interferon Treatment
Official title: Sustained HBsAg and Viral Response in Patients Achieved HBsAg Loss by Interferon Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis B
Keywords: HBsAg loss, interferon, HBV reaction
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2015-01-13
Enrollment: 420
Sex: ALL
Minimum age (years): 2
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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).

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.

Eligibility criteria: Inclusion Criteria:

* Patients who had chronic hepatitis B and achieved HBsAg loss by interferon treatment.

Exclusion Criteria:

* Active consumption of alcohol and/or drugs
* Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
* History of autoimmune hepatitis
* Psychiatric disease
* Evidence of neoplastic diseases of the liver

Primary outcomes:
measure: The rate of sustained HBsAg negativity and viral response in 96 weeks
timeFrame: From the enrollment to 96 weeks
Secondary outcomes:
measure: The rate of sustained HBsAg negativity and viral response in long term
timeFrame: From the enrollment to 240 weeks
measure: The rate of sustained HBsAg negativity and viral response in subset analysis in 96 weeks
timeFrame: From the enrollment to 96 weeks
measure: The rate of sustained HBsAg negativity and viral response in subset analysis for long term
timeFrame: From the enrollment to 240 weeks
measure: Predictor(s) for recurrence of HBsAg positivity or detectable levels of HBV DNA in 96 weeks
timeFrame: From the enrollment to 96 weeks
measure: Predictor(s) for recurrence of HBsAg positivity or detectable levels of HBV DNA in long term
timeFrame: From the enrollment to 240 weeks
Other outcomes:
measure: Exploratory outcomes on complication rates of liver cancer and decompensated cirrhosis in 96 weeks
timeFrame: from the enrollment to the 96 weeks
measure: Exploratory outcomes on complication rates of liver cancer and decompensated cirrhosis in 240 weeks
timeFrame: from the enrollment to the 240 weeks
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital,Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Ditan Hospital, Beijing, China
name: Yao Xie, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pan CQ, Li MH, Yi W, Zhang L, Lu Y, Hao HX, Wan G, Cao WH, Wang XY, Ran CP, Shen G, Wu SL, Chang M, Gao YJ, Xie Y. Outcome of Chinese patients with hepatitis B at 96 weeks after functional cure with IFN versus combination regimens. Liver Int. 2021 Jul;41(7):1498-1508. doi: 10.1111/liv.14801. Epub 2021 Feb 16.