Efficacies of Entecavir Add on HBeAg Positive Patients With HBV DNA Positive During Peginterferon Alpha 2a Treatment
- Registration Number
- NCT02368288
- Lead Sponsor
- Beijing Ditan Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- HBeAg positive patients with HBV DNA load ≥1000copies/ml after 6 months of peginterferon a-2a treatment
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description entecavir with PEG-IFN a-2a entecavir after enrolled, entecavir will added, and patients will receive treatment of PEG-IFN a-2a combine with entecavir for 48 weeks.
- Primary Outcome Measures
Name Time Method rate of HBeAg seroconversion 48 weeks HBeAg seroconversion defined as HBeAg loss with anti-HBe antibody positive was evaluated during weeks treatment period
- Secondary Outcome Measures
Name Time Method rate of HBsAg loss 48 weeks HBsAg loss defined as HBsAg level ≤0.05 IU/ml after 48 week treatment
Trial Locations
- Locations (1)
Beijing Ditan hospital,Capital Medical University
🇨🇳Beijing, Beijing, China