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.
Phase 4
Recruiting
- Conditions
- prevent Hepatitis B virus re-infection following liver transplantation with the use of tenofovir and lamivudine, withdrawing HBIG.Infection - Other infectious diseasesOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12611001236987
- Lead Sponsor
- Professor Peter Angus
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The aim of the proposed study is to assess the safety and efficacy of switching to tenofovir and lamivudine<br>therapy in patients who have been receiving long-term HBIg and lamivudine prophylaxis post-liver<br>transplant. primary endpoint will be the rate of hepatitis B recurrence as assessed by the appearance of HBsAg and HBVDNA in serum at 96 weeks post enrollment . This will be done on blood tests. Patients will be assessed every 3 months by medical staff and have monthly blood tests monitoring the Hepatitis B sAg and DNA and its recurrence.[An initial analysis of outcomes will be performed at 48 weeks and then at 96 weeks.]
- Secondary Outcome Measures
Name Time Method