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RecruitingPhase 4ACTRN12606000283572

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.

Sponsor

Prof. Meng Ngu, Concord Hospital

Enrollment

28 participants

Start Date

Jul 1, 2006

Study Type

Interventional

Conditions

Chronic Hepatitis B Virus Infection

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is an extension study for patients who already participated in earlier clinical trials of adefovir dipivoxil (Hepsera), a medication used to treat chronic hepatitis B. Because these participants have never taken lamivudine (another hepatitis B drug), they cannot access Hepsera at a reduced government price. This extension study allows them to continue receiving the medication free of charge while their long-term safety and effectiveness are monitored. You may be eligible if: - You are 18 years or older - You previously participated in and completed one of the original adefovir clinical trials (GS-98-437, GS-98-438, or GS-00-480) - You are currently taking adefovir dipivoxil 10 mg once daily You may NOT be eligible if: - You are pregnant or breastfeeding - You have a known allergy to adefovir, adefovir dipivoxil, or any ingredient in the tablets Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 follo

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)

Australia

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ACTRN12606000283572

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