An Open-Label Study Evaluating the Antiviral Activity of Tenofovir Disoproxil Fumarate (DF) 300mg in Patients with Chronic Hepatitis B Infection and Persistent Viral Replication after Long-Term Therapy with Adefovir Dipivoxil 10mg Daily

Phase 2

Recruiting

• Conditions: Hepatitis B; Inflammatory and Immune System - Liver

• Registration Number: ACTRN12606000381583
• Lead Sponsor: Austin Health (investigator initiated)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-08-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Male and non-pregnant/non-lactating female HBV infected patients. Patients who are currently receiving adefovir dipivoxil 10 mg daily in combination with lamivudine will be eligible for enrollment. Inclusion criteria include:·Chronic hepatitis B infection defined by positive serum hepatitis B surface antigen (HBsAg) for at least 6 months· Failed lamivudine therapy;· Active chronic hepatitis B infection:o hepatitis B E antigen (HBeAg) negative OR HBeAg positiveo Serum HBV DNA greater or equal to 105 (HBeAg positive) or 104 (HBeAg negative) copies/ml at screening while receiving continuous therapy with adefovir dipivoxil 10mg daily for at least 24 weeks.· Written informed consent.

Exclusion Criteria

Female who is pregnant or breastfeeding;· Female of childbearing potential who is unwilling to use effective contraception method while enrolled in the study;· Decompensated liver disease defined as bilirubin > 1.5 times the upper limit of normal (ULN), prothrombin time (PT) > 1.5 times the ULN, platelets < 75,000/mm3, serum albumin < 30g/l or prior history of clinical hepatic decompensation;· Evidence of hepatocellular carcinoma (alpha-fetoprotein > 50mg/l);· Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV) or hepatitis D virus (HDV);· Significant renal cardiovascular, pulmonary or neurological disease;· The following laboratory values obtained within 30 days prior to study entry:o Creatinine clearance < 70 ml/mino haemoglobin (Hb) < 8g/dlo Leukocytes < 1000mm3.

Study & Design

• Study Type: Interventional
• Study Design: Not specified