This trial is active, not recruiting.

Condition chronic hepatitis b
Sponsor Beijing Ditan Hospital
Start date January 2012
End date December 2016
Trial size 120 participants
Trial identifier NCT02336399, DTXY002


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 -negative patients, and the ultimate treatment goal in CHB. However, some patients achieved HBsAg loss would reverse back to HBsAg positive, even occur HBV reactive. in this study, the viral and HBsAg response in patients achieved HBsAg loss by interferon treatment will be observed for two years after completed IFN treatment.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

the rate of sustained HBsAg response
time frame: 96 weeks

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Sustained HBsAg and Viral Response in Patients Achieved HBsAg Loss by Interferon Treatment
Description The patients with chronic hepatitis B and achieved HBsAg loss by 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, liver function tests were performed every 3 months also. The liver ultrasonic examination would be taken every 3-6 months. The primary endpoint is HBsAg reverse back to positive. The secondary endpoints is HBV DNA reaction.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Beijing Ditan Hospital.