EFFORT Further Extension Study

• Status: Unknown status
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to demonstrate that long-term treatment (up to six years) with telbivudine or telbivudine plus adefovir results in the regression in liver inflammation and fibrosis/cirrhosis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanfang Hospital of Southern Medical University
• Collaborators: Major Science and Technology Special Project of China Twelfth-Five-Year Project; Novartis
• Treatments: Adefovir; Adefovir dipivoxil; Telbivudine

Criteria

Inclusion Criteria:

1. Patients who completed EFFORT extension study.

2. Patients who had baseline (that is the week 0 of EFFORT study) HBV DNA <9 Log copies/mL and ALT ≥2×ULN.

3. Patients who are willing to participate in the further extension study.

4. Patient is willing and able to comply with the study drug regimen and all other study requirements.

5. Patients must give written informed consent before any assessment is performed.

Exclusion Criteria:

1. Poor compliance judged by investigators