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

Efficacies of Entecavir Add on HBeAg Negative Chronic Hepatitis B Patients With HBV DNA Load ≥1000 Copies/ml After 3 Months of Peginterferon Alpha 2a Treatment

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02365402

Enrollment

180

Registered

2015-02-18

Start date

2013-01-31

Completion date

2016-12-31

Last updated

2016-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Keywords

chronic hepatitis B, peginterferon, sustained viral response, entecavir, HBeAg

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.

Interventions

DRUGEntecavir

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Contacts

Primary Contactyao Xie

xieyao00120184@sina.com8610-84322489

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026