TDF VS LAM + ADV in LAM + ADV Treated LAM-resistant CHB Patients With Undetectable Hepatitis B Virus DNA

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will provide a rationale for switch from lamivudine plus adefovir to tenofovir monotherapy in Lamivudine plus Adefovir Treated Lamivudine-resistant chronic hepatitis B patients with Undetectable Hepatitis B Virus DNA

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

Details

• Lead Sponsor: Keimyung University Dongsan Medical Center
• Collaborators: Daegu Catholic University Medical Center; DongGuk University; Kyungpook National University; Kyungpook National University Hospital; Pusan National University Hospital; Yeungnam University; Yeungnam University Hospital
• Treatments: Adefovir; Adefovir dipivoxil; Lamivudine; Tenofovir

Criteria

Inclusion Criteria:

• Male and female patients aged 18 or older

• The CHB patients (both HBeAg-positive and - negative) who have at least 6 months undetectable HBV DNA (serum HBV DNA ≤ 20 IU/mL) after lamivudine plus adefovir combination therapy.

Exclusion Criteria:

• Patients with decompensated liver disease

• Patients with HCV, HDV or HIV

• Patients with HCC

• Serum ALT > 2x ULN level

• Serum creatinine > 2.0mg/dL

• Pregnant or lactating women

• Women who have a plan for pregnancy within the three coming years

• Patients who have uncontrolled severe concomitant diseases- severe cardiovascular diseases and other infection

• Those who have no capabilities to understand and sign an informed consent