Liver Transplantation Clinical Trial
Official title:
Pilot Study With Peginterferon, Ribavirin, and Boceprevir Prior to Transplantation to Clear Virus in Hepatitis C Genotype 1 Infected Individuals Undergoing Orthotopic Liver Transplantation
Verified date | July 2014 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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: |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Indiana University School of Medicine - IUHealth-University Hospital | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University | Merck Sharp & Dohme Corp. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of individuals who can remain HCV RNA undetected 6 months post orthotopic liver transplant after receiving peginterferon, ribavirin, and boceprevir. | The primary objective is to determine the number of individuals who can remain HCV RNA undetected 6 months post orthotopic liver transplant after receiving peginterferon, ribavirin, and boceprevir. The primary safety objective is to determine the safety and efficacy of peginterferon, ribavirin, and boceprevir in Hepatitis C, genotype I individuals undergoing orthotopic liver transplantation. | 6 months post orthotopic liver transplant | No |
Secondary | Safety and efficacy of peginterferon, ribavirin, and boceprevir in patients with genotype I undergoing orthotopic liver transplant for cirrhosis and/or hepatocellular carcinoma. | To determine the safety and efficacy of peginterferon, ribavirin, and boceprevir in patients with genotype I undergoing orthotopic liver transplant for cirrhosis and/or hepatocellular carcinoma as defined by incidence of severe infections (SBP, bacteremia) and new onset ascites and or encephalopahty. | 6 months post orthotopic liver transplant | Yes |
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