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.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001236987

Enrollment

Registered

2011-12-02

Start date

2010-09-01

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

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.

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 dail

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Post liver transplant recipients Patients transplanted for Hepatitis B Current prophylaxis- lamivudine and Hepatitis B immunoglobumlin

Exclusion criteria

those patients not transplanted for hepatitis B

Outcome results