NCT02368288

Efficacies of Entecavir Add on HBeAg Positive Patients With HBV DNA Positive During Peginterferon Alpha 2a Treatment

Efficacies of Entecavir Add on Chronic Hepatitis B Patients With HBV DNA Load ≥1000 Copies/ml After 6 Months Treatment of Peginterferon Alpha 2a

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Beijing Ditan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The aim of interferon therapy in HBeAg positive chronic hepatitis B was to make patients obtain immune control to hepatitis B virus defined as occurred HBeAg seroconversion and HBsAg loss with sustained viral response after treatment. However this target could not be get if patients keep HBV DNA positive during interferon treatment and offend relapse after withdraw of treatment. In this trail, Nucleoside(acid) analogues(NA) will add on patients with HBV DNA load ≥1000copies/ml after 6 months of interferon treatment, and the efficacies of the combine therapy were evaluated by the rates of HBeAg seroconversion and HBsAg loss after 48 weeks of combined therapy, compared with control group.

Detailed description

HBeAg positive patients with HBV DNA load ≥1000copies/ml after 6 months of peginterferon alpha 2a treatment will be enrolled randomized into two groups, in intervention group, patients will receive entecavir combine with peginterferon alpha 2a(PEG-IFN a-2a) treatment for 48 weeks and follow 24 weeks. Patients in control group will be continue treated with PEG-IFN a-2a for 48 weeks and followed 24 weeks. Serum HBV DNA load, HBsAg/anti-HBs level, HBeAg/anti-HBe will be tested at enrollment and every 3 months during the treatment course. Parameters of Liver and kidney function, and liver ultrasound examination will be tested with intervals 1-3 months. The efficacies of the combined therapy were evaluated by the rates of HBeAg seroconversion and HBsAg loss after 48 weeks of combined therapy, compared with control group.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	entecavir	in this group, entecavir will added, and patients will receive treatment of PEG-IFN a-2a combine with entecavir for 48 week.

Timeline

• Start date: 2013-01-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-02-23
• Last updated: 2016-08-18

Locations

1 site across 1 country: China