Adefovir Dipivoxil For The Treatment Of Patients With Chronic Hepatitis B Related Advanced Fibrosis Or Cirrhosis
Status:
Completed
Trial end date:
2009-09-01
Target enrollment:
Participant gender:
Summary
This 36-month open-label study of adefovir dipivoxil investigates the clinical benefits of
the therapy in chronic hepatitis B patients with advanced fibrosis or cirrhosis confirmed
with biopsy. Primary endpoint is histological improvement defined as a decrease of Ishak
Fibrosis Score by one point or more from baseline at Month 36 of adefovir dipivoxil
treatment. Approximately 150 patients will be recruited in study centres in the Asia Pacific
area. The patients are offered 36 months of open label adefovir dipivoxil treatment, with
assessments every three months, after which there is a 6-month post study treatment follow-up
prior to study completion. After the 36 months of study treatment, it is likely that the
patient will benefit from continued treatment with adefovir dipivoxil. If this is the case in
the investigators clinical judgement, the investigator should ensure that a routine
prescription is available in a timely manner, and that no unnecessary interruption in
treatment occurs.