Efficacy Optimizing Extension Study of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy (Dragon-Ex)

Nanfang Hospital, Southern Medical University

Status and phase: Unknown; Phase 4

Conditions: Nucleos(t)Ide Analogues Treatment; Chronic Hepatitis B; Inadequate Response

Treatments: Drug: Entecavir, Adefovir

Study type: Interventional

Funder types: Other

Identifiers

NCT01829685

MOH-06

Details and patient eligibility

About

The purpose of this study is to compare the long-term efficacy and safety of entecavir 1.0 mg/d + adefovir 10 mg/d with entecavir 0.5 mg/d + adefovir 10 mg/d for chronic hepatitis B patients with inadequate response to NUC therapy

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who completed the 104-week Dragon 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: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 2 patient groups

Group I

Active Comparator group

Description:

oral entecavir 1mg daily and adefovir 10mg daily for 144 weeks

Treatment:

Drug: Entecavir, Adefovir

Group II

Active Comparator group

Description:

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

Treatment:

Drug: Entecavir, Adefovir