None listed
Conditions
Brief summary
The purpose of the protocol is to provide people who not responding to current hepatitis B treatments another option.
Interventions
Treatment for patients who are no longer responding to current, registered treatments (lamivudine 100 mgs daily and adefovir 10 mgs daily)
The drug is tenofovir, at 300 mgs orally daily. Treatment is given indefinitely.
Sponsors
Austin Health (investigator initiated)
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed