Efficacy Optimizing Research of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy

A Multi-center, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Generic Entecavir Monotherapy or in Combination With Adefovir for Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01341743

Enrollment

360

Registered

2011-04-26

Start date

2010-12-31

Completion date

2014-12-31

Last updated

2013-10-30

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

Conditions

Hepatitis B

Keywords

chronic hepatitis B, inadequate response, NUC therapy

Brief summary

The purpose of this study is to evaluate the efficacy and safety of generic entecavir monotherapy or in combination with adefovir for chronic hepatitis B patients with inadequate response to NUC therapy

Interventions

DRUGEntecavir

patients will receive oral entecavir 1mg, daily for 104 weeks.

DRUGEntecavir, Adefovir

patients in this arm will receive oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Male or female aged 18-65 years; * Capable of understanding and signing the informed consent. Willing to comply with the study requirements; * Serum HBsAg positive and ALT\<10ULN at study screening; * Patients have been treated with one nucleoside/nucleotide analogue for more than 6 months and are still on treatment;

Exclusion criteria

* History of viral breakthrough or genotypic resistance on previous therapy; * History of decompensated liver function, or current signs/symptoms of decompensation e.g. ascites, variceal bleeding, encephalopathy or spontaneous peritonitis; * Patient has a history of hepatocellular carcinoma(HCC) or findings suggestive of possible HCC; * Other protocol defined

Design outcomes

Primary

Measure	Time frame
proportion of subjects with hepatitis B virus (HBV)DNA<300copies/ml at week 104	week 104

Secondary

Measure	Time frame
serum HBV DNA reduction from baseline at week 104	week 104
The proportion of subjects with ALT normalization at week 104	week104
The proportion of subjects with HBeAg loss and seroconversion at week 104	week104
The proportion of subject with HBsAg loss and seroconversion at week 104	week104
The proportion of subjects with mutations of rtN236T/A181V, rtL180M/rtM204V/rtT184/rtS202 and/or rtM250 at week 104	week104

Countries

China

Outcome results

None listed

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