NCT02336399

Sustained HBsAg and Viral Response in Patients Achieved HBsAg Loss by Interferon Treatment

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 420 (actual)
• Sponsor: Beijing Ditan Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis B

Timeline

• Start date: 2008-09-01
• Primary completion: 2016-12-01
• Completion: 2021-12-01
• First posted: 2015-01-13
• Last updated: 2017-11-14

Locations

1 site across 1 country: China