The Extension Study
A phase 4, open-label, multi-centre, observational extension study monitoring the long-term safety and efficacy of adefovir dipivoxil 10mg daily in treatment experienced patients with chronic hepatitis B.
Prof. Meng Ngu, Concord Hospital
28 participants
Jul 1, 2006
Interventional
Conditions
Summary
Adefovir dipivoxil 10mg tablets were approved for the treatment of chronic hepatitis B by the TGA in 2003 and are now marketed as Hepsera(r) by Gilead Sciences. Patients who are not resistant to another anti-hepatitis B virus drug called lamivudine are not able to access Hepsera at a PBS reimbursed price. Patients who participated in the adefovir dipivoxil clinical trials GS-98-437, GS-98-438, and GS-00-480 and are still taking adefovir dipivoxil have never received lamivudine and thus cannot receive Hepsera at reduced price. This study will allow the patients to continue accessing adefovir free of charge and provide unprecedented data on the long-term safety and efficacy of adefovir dipivoxil without changing the procedures and tests routinely done during normal visits to the clinic.
Eligibility
Exclusion Criteria1
- Pregnant or breastfeeding females• Known hypersensitivity to adefovir, adefovir dipivoxil, or any of the excipients in adefovir dipivoxil tablets.
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Interventions
adefovir dipivoxil 10mg tablets daily. Patients have been receiving adefovir dipivoxil for approx. 5 years prior to study entry and will be receiving adefovir post completion if appropriate. The follow-up period for the extension study will also be 5 years.
Locations(1)
View Full Details on ANZCTR
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ACTRN12606000283572