Pilot Study With Peginterferon, Ribavirin, and Boceprevir Prior to Transplantation to Clear Virus in Hepatitis C Genotype 1 Infected Individuals Undergoing Orthotopic Liver Transplantation

Completed · Early Phase 1

Conditions studied: Liver Transplantation

In brief

Currently, there is no treatment standard for use of anti-HCV (hepatitic C virus) medications for those preparing for a liver transplant. The purpose of this study is to determine whether those individuals who require liver transplantation for Hepatitis C, genotype I, who are undergoing liver transplantation may successfully get rid of their virus before the transplant by taking three medicines, peginterferon, ribavirin, and boceprevir, up until the time of the liver transplant surgery. If successful, the Hepatitis C virus will not re-infect the new liver that they receive and they will not require therapy for Hepatitis C after liver transplantation. This study involves the use of peginterferon alfa-2b, ribavirin, and boceprevir, all of which are approved for the treatment of genotype I Hepatitis C. Hypothesis: The addition of boceprevir to peginterferon alfa-2b and ribavirin in patients with Hepatitis C genotype 1 with or without hepatocellular carcinoma undergoing orthotopic liver transplantation will lead to rapid HCV RNA clearance of genotype I infected individuals. Transplantation with anhepatic boceprevir will prevent reinfection of the new transplanted graft and prevent graft infection posttransplantation.

Key facts

Study ID

NCT01909401

Run by

Indiana University

People needed

1

Starts

2013-06-01

Expected to finish

2014-07-01

Last updated by the study team

2014-07-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women age 18-70
• Patients must be genotype I HCV-infected individuals with cirrhosis undergoing orthotopic liver transplantation.
• Those with hepatocellular carcinoma with or without treatment of hepatoma may also be included.
• The MELD score for enrollment will be capped at 16.
• Patients must have medically controlled ascites and those who have moderate or poorly controlled ascites will be excluded.
• Inclusion Laboratory Values
• ALT (alanine aminotransferase) < 250 IU/L, AST (Aspartate aminotransferase ) < 250 IU/L, total bilirubin < 3 mg/dl, creatinine clearance > 45 ml by MDRD (Modification of Diet in Renal Disease), albumin > 2.8 g/dl, hemoglobin > 11, white count > 2.0 X103, absolute neutrophil count 1.5 X103, platelet count > 50,000.
• Women of childbearing potential and male patients with sexual female partner who is of childbearing potential should use two acceptable methods of contraception.

Where it is running

• Indiana University School of Medicine - IUHealth-University Hospital — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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