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

NCT01909401 | Completed Early Phase 1 DMC

• 1 other identifier: 1301010500
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Liver Transplantation

Keywords

Liver Transplantation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Safety and efficacy of peginterferon, ribavirin, and boceprevir in patients with genotype I undergoing orthotopic liver transplant for cirrhosis and/or hepatocellular carcinoma.

  6 months post orthotopic liver transplant

Interventions

boceprevir DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.

Sponsors & Collaborators

• Indiana University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Indiana University School of Medicine - IUHealth-University Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Interventions

N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide

Study Officials

• Paul Y Kwo, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2013
• First Posted: July 26, 2013
• Study Start: June 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 24, 2014

Record last verified: 2014-07

Locations

US (1)