3E Extension Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-12-31

Brief Summary

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The purpose of this study is to evaluate the long-term efficacy and safety of entecavir 0.5 mg/d + adefovir 10 mg/d for treatment experienced chronic hepatitis B patients.

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Detailed Description

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Conditions

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Chronic Hepatitis B

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group

Group Type OTHER

oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks

Intervention Type DRUG

Interventions

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oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects who completed the EXPLORE or EXCEL studies, or subjects with hepatitis flare after treatment withdrawal in EFFORT study.
* Subjects who are willing to participate the extension study.

Exclusion Criteria

* Subjects who could not compliance with the protocol judged by investigators

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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