NCT01088009

Efficacy Optimizing Research of Lamivudine Therapy

A Prospective, Randomised, Open-label, Multi-centre Study to Compare Three Chronic Hepatitis B (CHB) Treatment Strategies Over a 2year Period in Chinese HBeAg Positive CHB Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 366 (actual)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the adefovir early add-on to rescue therapy strategy, and also explore the efficacy of Lamivudine and adefovir de-novo combination therapy.

Conditions

• Compensated Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	lamivudine	patients in this arm will receive oral lamivudine 100mg,daily for 24 weeks; if patients with HBV DNA higher than 1000 copies/ml at week 24, add on adefovir to week 104; otherwise, keep lamivudine monotherapy to week 104
DRUG	lamivudine	Patients will receive oral lamivudine 100mg,daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily
DRUG	lamivudine, adefovir	patients in this arm will receive oral lamivudine 100mg daily and adefovir 10mg for 104 weeks

Timeline

• Start date: 2010-03-01
• Primary completion: 2013-02-01
• Completion: 2013-05-01
• First posted: 2010-03-16
• Last updated: 2013-10-30

Locations

24 sites across 1 country: China