3E Extension Study

Nanfang Hospital, Southern Medical University

Status and phase: Unknown; Phase 4

Conditions: Chronic Hepatitis B

Treatments: Drug: oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks

Study type: Interventional

Funder types: Other

Identifiers

NCT01834508

MOH-07

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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600 participants in 1 patient group

Treatment group

Other group

Treatment:

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