Project Title: The A2ALL LADR Protocol: Pre-Transplant Treatment to Prevent Recurrence of Hepatitis C After Living Donor Liver Transplantation (sub-study to main A2ALL study).
Purpose:
The purpose of this study is to learn if pre-liver transplant treatment using peginterferon plus ribavirin will clear HCV RNA from the blood in HCV-infected recipients, and reduce the risk of recurrent HCV and re-infection of the new liver with hepatitis following liver transplant. Patients awaiting deceased donor liver transplant will be asked to enroll in this protocol at the time of identification of a potential living liver donor. This study involves about nine centers in the United States and will be enrolling 150 patients in this study over a four-year period.
Inclusion trial criteria:
Sponsor:
NIH/Schering-Plough/Ortho-Biotech
Primary Investigator:
Laura Kulik, MD
Cost:
None
Contact:
Patrice Al-Saden, RN (312) 503-1058
IRB Project Number:
1530-002
Project Title: Genes Related to HCC Progression on Living Donor and Deceased Donor Transplant Recipients
Purpose:
We will explore the hypothesis that establishment of a molecular-based method for the classification of Hepatitis C/liver cancer at diagnosis will permit the detection of distinct subgroups of liver cancer patients with different prognoses, allowing greater accuracy in selection of patients for treatment cure with transplantation.
This study hopes to identify the genes involved in the development of liver cancer in patients with Hepatitis C cirrhosis. In addition, we plan to examine the genes implicated in tumor progression in patients with Hepatitis C/liver cancer while waiting for transplantation. Finally, this study looks to determine the potential role of the genetic markers in predicting post-transplantation outcomes in Hepatitis C-infected patients with liver cancer.
Inclusion trial criteria:
All patients with a diagnosis of hepatocellular carcinoma from August 1, 1994 through October 31, 2005. This will encompass the time frame in which the liver transplant program was started through its current day.
Sponsor:
NIH
Primary Investigator:
Laura Kulik, MD
Cost:
None
Contact:
Patrice Al-Saden, RN (312) 503-1058
IRB Project Number:
1530-008
Project Title:
A2ALL Human Liver Explants for HIF-1 Alpha Analysis/Comparison
Purpose:
The primary study objective is to compare levels of HIF-1α (Hypoxia Inducing Factor 1-alpha) expression in HCC tumor explants which have received: 1) no pre-explant embolization; 2) pre-explant TACE; 3) pre-explant Y90 radioembolization; 4) pre-explant radiofrequency ablation, or; 5) a combination of pre-explant therapies. .
Inclusion trial criteria:
Sponsor:
Divisional
Primary Investigator:
Laura Kulik, MD
Cost:
None
Contact:
Patrice Al-Saden, RN (312) 503-1058
IRB Project Number:
1530-004
Project Title: PROTECT. Pegylated Interferon alfa-2b and Ribavirin After Orthotopic Liver Transplantation: Efficacy and Safety in Hepatitis C Recurrence Therapy
Purpose:
The primary endpoint for this study will be to determine the sustained virologic response (SVR) at the 24-week follow up after treatment with PEG-IFN ά-2b and Ribavirin in post-orthotopic liver transplant (OLT) recipients with recurrent HCV.
Inclusion trial criteria:
Patients whom have had a liver transplant for end stage liver disease due to recurrent HCV.
Sponsor:
Integrated Therapeutics/ Schering Plough
Primary Investigator:
Laura Kulik, MD
Cost:
None
Contact:
Karen Matijevich, RN (312) 503-5213
Project Title:
Immune Tolerance and Alloreactivity in Liver Transplant Recipients on Different Monotherapy Immunosuppressive Agents
Purpose:
This study is a pilot investigation comparing immune tolerance and alloreactivity profiles in Liver transplant recipients on Monotherapy IS or being converted to rapamycin or MMF Monotherapy, to determine baseline tolerogenic properties of the different IS agents and support larger scale investigation if significant trends are observed. In addition, this data may lead to protocol development involving the selection of patients on specific agents for further immune tolerance study, conversion, minimization and/or withdrawal.
Inclusion trial criteria:
Sponsor:
Divisional
Primary Investigator:
Josh Levitsky, MD
Cost:
None
Contact:
Anne Rosen, RN (312)503-0444
IRB Project Number:
1783-011
Project Title: Liver Transplant Protocol for HIV-infected Recipients
Purpose:
The primary aim of this study is to evaluate the safety and efficacy of solid organ transplantation in people with HIV disease by conducting a prospective, multi-center cohort study of HIV-positive (+) patients who undergo kidney or liver transplantation. Our long-range goals are: (1) to provide patients and clinicians with information regarding the HIV-specific risks of transplantation, (2) to provide clinicians with information necessary to manage immunosuppressive and antiretroviral (ARV) medications together, and (3) to understand underlying basic science mechanisms that explain patient outcomes so that clinical management may be adjusted to maximize these outcomes.
Inclusion trial criteria:
All individuals with decompensated or end stage liver disease and HIV infection who otherwise meet standard clinical criteria for liver transplantation will be evaluated for liver transplantation. Organ transplant candidates with HIV infection must have evidence of sustained viral suppression, long-term stabilization of the immune system, and no active opportunistic infections, malignancies, or wasting disease.
Sponsor:
NIAID
Primary Investigator:
Tina Stosor, MD
Cost:
None
Contact:
Sarah Hively-Johnson (312)503-1056
IRB Project Number:
0988-013
