NCT00347009

Adefovir Dipivoxil For The Treatment Of Patients With Chronic Hepatitis B Related Advanced Fibrosis Or Cirrhosis

An Open Label Study of Adefovir Dipivoxil for the Treatment of Patients With Chronic Hepatitis B Related Advanced Fibrosis or Cirrhosis.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis B, Chronic
• Cirrhosis
• Fibrosis
• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	adefovir dipivoxil	10mg once daily

Timeline

• Start date: 2005-05-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2006-07-04
• Last updated: 2012-06-04
• Results posted: 2010-10-15

Locations

12 sites across 5 countries: Hong Kong, Singapore, South Korea, Taiwan, Vietnam