EFFORT Extension Study (EFFORT-Ex)

Nanfang Hospital, Southern Medical University

Status and phase: Unknown; Phase 4

Conditions: Hepatitis B, Chronic

Treatments: Drug: telbivudine (ROADMAP); Drug: Telbivudine (Standard of Care)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01529255

MOH-05

Details and patient eligibility

About

• The purpose of this study is to to prove that the long-term efficacy of strategy of treatment adjustment at W24 according to virological response based on ROADMAP concept is better than standard of care strategy.
• To evaluate the off-treatment durability of HBeAg seroconversion in patients who discontinued treatment due to sustained HBeAg seroconversion and HBV DNA<300copies/ml with over 12 months consolidation treatment

Enrollment: 576 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treated with telbivudine or combined with adefovir in EFFORT study
• Patients are willing to participate in the extension study
• Patients provide information consent form

Exclusion criteria

• Adjustment of poor compliance by investigators

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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576 participants in 2 patient groups

ROADMAP

Experimental group

Treatment:

Drug: telbivudine (ROADMAP)

SOC (Standard of Care)

Active Comparator group

Treatment:

Drug: Telbivudine (Standard of Care)