Study Title: Evaluation of HepaGam B®in Combination with Antiviral Treatment in Hepatitis B Liver Transplant Patients
(IRB# 007-287)

Short Title: Cangene

Study Description: Chronic hepatitis B is a disease which is recognized as a reason for liver transplant.  Patients will usually receive treatment for their hepatits B before transplant to try to decrease the amount of virus in their body.
After transplant, however, the hepatitis B virus may still remain in the patient’s body and can cause the new liver to become infected.  For this reason oftentimes patients will also receive treatment with anti-hepatitis B medication after transplant to slow down or prevent the recurrence of the hepatitis B virus.  
HepaGam B®is often times used after liver transplant to help prevent or slow down recurrence of hepatitis B. Previous studies have shown it to be effective and it has been approved by the FDA to be used for this reason.  This study is being done to find out more information about how HepaGam B is processed by the body when it is taken with other antiviral medicines. This will be done by measuring the amount of HepaGam in the blood at different times.

Some of the criteria for patients to qualify for the study include:

• Patient is at least 18 years of age.
• HBsAg-positive candidates for HBV-related liver transplant

The following are some of the criteria which will exclude patients from the study:

• Liver re-transplantation except for primary non-function
• Multi-organ transplantation recipients

Location:
Baylor University Medical Center                                             
Roberts Building-4th Floor                             
Dallas, TX 75246

Lead Principal Investigator: Robert Perrillo, MD

For further information about this study, please contact: 214-820-6622 or ElizabGr@baylorhealth.edu or you can complete our online form and a research coordinator will get back to you.