RecruitingPhase 4ACTRN12611001236987

Asses the safety and efficacy of switching to tenofovir and lamivudine therapy in patients who have been receiving Hepatitis B Immunoglobulin and lamivudine prophylasix post liver transplant.

A study to assess the safety and efficacy of tenofovir disoproxil fumarate (TDF) substitution for HBIg in liver transplantation patients receiving long-term low dose IM HBIg / lamivudine (LAM) prophylaxis.

Sponsor

Professor Peter Angus

Enrollment

40 participants

Start Date

Sep 1, 2010

Study Type

Interventional

Conditions

prevent Hepatitis B virus re-infection following liver transplantation with the use of tenofovir and lamivudine, withdrawing HBIG.

Summary

The use of the combination of lamivudine (LAM) and low dose hepatitis B immune globulin (HBIg) prophylaxis has had a major impact on the rate of recurrence of hepatitis B following liver transplantation. However, the long-term use of HBIg is extremely costly and very inconvenient for patients. There is a clear need to develop an alternative more convenient and less costly long-term prophylactic regimen for use in this patient group. The aim of the proposed study is to assess the safety and efficacy of switching to tenofovir and lamivudine therapy in patients who have been receiving long-term HBIg and lamivudine prophylaxis post-liver transplant.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for people who have received a liver transplant because of Hepatitis B and are now taking two medications — lamivudine and hepatitis B immunoglobulin (HBIg) — to prevent the Hepatitis B from coming back. HBIg is very expensive and inconvenient (it must be given by injection). This trial tests whether switching to a different combination — lamivudine plus tenofovir — is just as safe and effective, and much easier to manage long-term. You may be eligible if: - You are 18 years or older - You received a liver transplant because of Hepatitis B - You are currently taking lamivudine and HBIg as your post-transplant preventive treatment You may NOT be eligible if: - You received your liver transplant for a reason other than Hepatitis B 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

Patients originally receiving Lamivudine and Hepatitis B immunoglobulin will now receive lamivudine 100mg orally daily and tenofovir 300mg orally daily- Hepatitis B Immunoglobulin (HBIG) will be ceased once starting tenofovir. Patients will be excluded if they have evidence of HBV viral recurrence. In the screening phase the patients will be HBsAg negative and HBV DNA negative by PCR. At visit 1 the patient will be switched from HBIG and lamivudine to lamivudine and Tenofovir and taken once daily, orally, in the morning. The dose will be adjusted of both drugs according to renal function. The drugs will continue for the duration of the study- which is 5 years.

Locations(1)

New Zealand

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ACTRN12611001236987