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.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000283572

Enrollment

Registered

2006-07-05

Start date

2006-07-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

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

Inclusion criteria

Comment: Since this study is an extension study to studies 437/438/480, minimal inclusion/exclusion criteria apply. (The original study included both male and female participants over the age of 18 years). Inclusion:• Participation in and completion of study GS-98-437, GS-98-438 or GS-00-480.• Currently treated with adefovir dipivoxil 10mg once a day.

Exclusion criteria

Pregnant or breastfeeding females• Known hypersensitivity to adefovir, adefovir dipivoxil, or any of the excipients in adefovir dipivoxil tablets.

Outcome results