Pilot Study With Peginterferon, Ribavirin, and Boceprevir Prior to Transplantation to Clear Virus in Hepatitis C Genotype 1 Infected Individuals Undergoing Orthotopic Liver Transplantation
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 10/19/2013 |
| Start Date: | June 2013 |
| End Date: | September 2014 |
| Contact: | Alicia G Limbach, LPN |
| Email: | aglimbac@iu.edu |
| Phone: | 317-278-8118 |
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.
Subject Patient Inclusion Criteria: Men and women age 18 to 70 inclusive, patients with
genotype I Hepatitis C who are listed for orthotopic liver transplantation (OLT) will be
enrolled. 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.
Treatment Plan: Fifteen patients with chronic genotype I Hepatitis C will be enrolled. All
patients will begin with peginterferon and ribavirin for 4 weeks with the addition of
boceprevir after Week 4 until orthotopic liver transplantation. The dose of interferon will
be peginterferon 1.0 mcg/kg with weight-based ribavirin (600-1200 mg) with boceprevir 800
mg TID (three times per day) until OLT. All patients will be listed for orthotopic liver
transplantation. HCV RNA will be measured monthly. When they are called in for transplant,
they will take their last dose of ribavirin just prior to going to operating room. Patients
will undergo orthotopic liver transplantation under standard protocol by Indiana University.
They will receive by Dobhoff boceprevir 800 tid for 3 doses post transplantation.
Virologic failure will be HCV RNA > 100 I.U. at Week 12.
Inclusion Criteria:
- 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.
Exclusion Criteria:
-
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