Efficacy of Long-term Telbivudine Treatment on Histological Improvements in Patients With Chronic Hepatitis B (EFFORT Further Extension Study)

NCT02826070 Phase 4 UNKNOWN

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.

Details

Lead sponsor	Nanfang Hospital, Southern Medical University
Phase	Phase 4
Status	UNKNOWN
Enrolment	130
Start date	2015-04
Completion	2017-10

Conditions

• Hepatitis B, Chronic

Interventions

• Telbivudine
• Adefovir dipivoxil
• off-treatment follow-up

Primary outcomes

• Percentage of patients with histological improvement (≥2-point decrease in the Knodell necroinflammatory score and no worsening in Ishak fibrosis score). — Week 48

Countries

China