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

Phase 4

• Conditions: Chronic Hepatitis B
• Interventions: Drug: Entecavir

• Registration Number: NCT02365402
• Lead Sponsor: Beijing Ditan Hospital

Brief Summary

The aim of interferon therapy in HBeAg negative chronic hepatitis B was to make patients obtain immune control to hepatitis B virus defined as 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 treatment withdraw. In this trail, entecavir will add on patients with HBV DNA load ≥1000copies/ml after 3 months of peginterferon alpha 2a treatment, and the efficacies of the combine treatment will be evaluated by the rate of sustained viral response after 48 weeks of treatment and 24 week follow up.

Detailed Description

HBeAg negative patients with HBV DNA load ≥1000copies/ml after 3 months of peginterferon alpha 2a treatment would be randomize enrolled into two groups, in Interventional group, patients will receive entecavir combine with peginterferon alpha 2a treatment for 48 weeks and followed 24 weeks. Patients in control group will be continue treated only by peginterferon alpha 2a for 48 weeks 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 the treatment course. Parameters of Liver and kidney function, and liver ultrasound examination will be tested with intervals 1-3 months. The efficacies of combined therapy were evaluated by the rate of sustained viral response after 48 weeks treatment and 24 weeks follow up compared with control group.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2015-02-15
• Study First Submitted QC: 2015-02-15
• Study First Posted: 2015-02-18
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-17
• Last Update Posted: 2016-08-19
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• HBeAg negative patients with HBV DNA load ≥1000copies/ml after 3 months of peginterferon a-2a 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

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 and 24 weeks of follow up after treatment.

Primary Outcome Measures

Name	Time	Method
rate of sustained virual response	72 weeks	sustained viral response was defined as serum HBV DNA load was undetectable at the end of treatment and 24 weeks of follow-up.

Secondary Outcome Measures

Name	Time	Method
rates of HBsAg loss during treatment course and at the end of follow-up	72 weeks	HBsAg loss defined as HBsAg level ≤0.05 IU/ml

Trial Locations

Locations (1)

Beijing Ditan hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China