NCT02387684

Efficay of Extended Peginterferon Alpha 2a Treatment in HBeAg Negative Chronic Hepatitis B Patients

Efficay of Extended Peginterferon Alpha 2a(PEG-IFN a-2a) Treatment in HBeAg Negative Chronic Hepatitis B Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Beijing Ditan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The most important method to slow down and stop the liver disease progression in patients with chronic hepatitis B is antiviral therapy, by which to achieve maintaining viral response during treatment or obtain sustained viral response after treatment. The aim of the therapy with interferon is make patients obtain immune control to HBV defined as sustained viral response after treatment, however, most patients can't get this target after 48 weeks of interferon treatment, and some patients need extended treatment in clinical practice to enhance the rate of sustained viral response or HBsAg loss occurred during treatment. In this cohort study, the efficacy of extended therapy of interferon in HBeAg negative chronic hepatitis B patients will be evaluated.

Detailed description

In this cohort study, the HBeAg negative chronic hepatitis B patients would be treated with peginterferon alpha 2a(PEG-IFN a-2a) for 96 week and followed 24 weeks after treatment. Serum HBV DNA load, HBsAg/anti-HBs level, HBeAg/anti-HBe will be tested at enrollment and every 3 months during treatment and follow period. Parameters of liver and kidney function, and liver ultrasound examination will be tested with intervals 1-3 months. The efficacies were evaluated by the rate of HBsAg loss during treatment and the rate of sustained viral response after treatment and follow up.

Conditions

• Chronic Hepatitis B

Timeline

• Start date: 2012-04-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-03-13
• Last updated: 2016-08-19

Locations

1 site across 1 country: China