Clinical Trial Result Information

Protocol number
MCT00059267

Title of Study
Prevention of Recurrent Hepatitis B After Liver Transplantation

Sponsor
Roche Molecular Systems

Company division
Diagnostic

Product name
CA HBV MONITOR RUO

Therapeutic area
Hepatitis B, Chronic

Clinical study summary
This was a non-randomized, open-label, single arm study to establish the most cost-effective preventive therapy for recurrent hepatitis B after liver transplantation.

Study center(s)
12 centers in the USA.

Phase of development
NA

Objectives
To establish a database of all patients transplanted for hepatitis B virus (HBV) within the participating centers; determine risk factors for recurrent HBV post-liver-transplantation (LT); determine optimal prophylactic therapy for prevention of recurrent HBV; determine efficacy of lamivudine + peri-operative IV HBIG in prevention of recurrent HBV post-LT; determine post-LT outcome of patients who have lamivudine resistant HBV; determine outcome of patients with recurrent HBV post-LT and the long-term safety and efficacy of adefovir in these patients.

Methodology
The study used the Roche COBAS AMPLICOR HBV MONITOR Test, RUO viral load molecular test to measure serum viral DNA levels in patients awaiting or who had received a transplanted liver for the treatment of hepatitis B. In addition, the study quantified intrahepatic DNA levels using an investigator designed assay.

Number of patients (planned/analyzed)
500 planned/analyzed

Diagnosis and main criteria for inclusion
Patients awaiting or who had received liver or combined liver-kidney transplantation for hepatitis B cirrhosis, hepatitis B liver cancer and fulminant hepatitis B.

Criteria for evaluation (efficacy, safety)
Viral DNA levels of transplanted patients together with serology were used to compare treated (through various parallel drug regimens) and untreated arms of the study.

Statistical methods
Statistical analyses were performed by SPSS software (version 13.0). Continuous variables were expressed as median (range) unless otherwise indicated, and compared using the Mann-Whitney U-test. Correlation of DNA levels was by the Pearson correlation test. All statistical tests were 2-sided.

Summary (efficacy, safety, other results)
Total but not ccc HBV DNA could be detected in explant livers of most patients despite antiviral therapy post-orthotopic liver transplant (OLT). The Roche HBV Monitor viral load standardized test together with the investigator designed cccDNA test showed that transplanted HBV infected livers would still harbour HBV virus, but under treatment overt HBV disease could be prevented.

Conclusions
The findings suggest that occult HBV reinfection occurs in most HBV patients after OLT and continued administration of appropriate prophylactic therapy is important in preventing overt HBV recurrence.

Publications (references, if available)
Liver Transplantation 13:1137-1144, 2007 

Date of report
2/18/2008

Click here for the protocol registry listing of this trial.