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

Capital Medical University

Status and phase: Unknown; Phase 4

Conditions: Chronic Hepatitis B

Treatments: Drug: Entecavir

Study type: Interventional

Funder types: Other

Identifiers

NCT02365402

DTXY006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

entecavir with PEG-IFN a-2a

Experimental group

Description:

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.

Treatment:

Drug: Entecavir

control group

No Intervention group

Description:

In this group, patients will be continue treated only by PEG-IFN a-2a for 48 weeks after enrolled and receive 24 weeks of follow up.