Status:
COMPLETED
Pilot Study With Peginterferon, Ribavirin, and Boceprevir Prior to Transplantation to Clear Virus in Hepatitis C Genotype 1 Infected Individuals Undergoing Orthotopic Liver Transplantation
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Liver Transplantation
Eligibility:
All Genders
18-70 years
Phase:
EARLY_PHASE1
Brief Summary
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 indivi...
Detailed Description
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 he...
Eligibility Criteria
Inclusion
- 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
- \-
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01909401
Start Date
June 1 2013
End Date
July 1 2014
Last Update
July 24 2014
Active Locations (1)
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1
Indiana University School of Medicine - IUHealth-University Hospital
Indianapolis, Indiana, United States, 46202