Open Label Study of the Efficacy and Safety of MBL-HCV1 in Combination With Telaprevir in Patients Undergoing Liver Transplantation for Hepatitis C

• Evaluate the safety and tolerability as assessed by adverse events, concomitant medication use, physical examination, clinical laboratory evaluation [ Time Frame: Day 98 ] [ Designated as safety issue: Yes ]
• Proportion of subjects with undetectable HCV RNA at multiple time points through at least 6 weeks after end of treatment [ Time Frame: Day 98 ] [ Designated as safety issue: No ]
• Evaluate the reduction in viral load as compared with pre-transplant HCV RNA levels [ Time Frame: Day 98 ] [ Designated as safety issue: No ]
• Determine HCV resistance-associated variants to MBL-HCV1 and protease inhibitor before and after receipt of study treatment [ Time Frame: Day 98 ] [ Designated as safety issue: No ]

The purpose of this study is to assess efficacy of a human monoclonal antibody against Hepatitis C (MBL-HCV1) combined with telaprevir, an HCV protease inhibitor, in a 56 day treatment duration in patients undergoing liver transplantation due to chronic HCV infection.

• Biological: MBL-HCV1
  50 mg/kg MBL-HCV1, intravenous, up to 15 infusions over 56 days
• Drug: Telaprevir
  Two 375 mg tablets, 3 times a day up to 56 days
  Other Name: Incivek (telaprevir)

Inclusion Criteria:

• Patient ≥ 18 years of age with documented chronic hepatitis C virus infection of genotype 1a undergoing liver transplantation from either a deceased donor or living donor.
• Patient or legal guardian/health care proxy must have read, understood and provided written informed consent and HIPAA authorization after the nature of the study has been fully explained.

Exclusion Criteria:

• Positive for hepatitis B surface Antigen
• Positive serology for HIV
• Pregnancy or Breastfeeding
• Previous history of any organ transplant
• Planned receipt of combined organ transplant (e.g. liver and kidney)
• Receipt or planned receipt of immune globulin (IVIG) within 90 days of enrollment
• Extrahepatic malignancy not currently in remission and/or receiving systemic chemotherapy and/or radiation within 90 days prior to enrollment. Exceptions include chemoembolization for hepatocellular carcinoma or cutaneous malignancies managed with local treatment
• Hepatocellular carcinoma with tumor burden outside of the Milan criteria
• Serum creatinine > 2.5 for > or = six months at the time of enrollment
• Personal or family history (first degree relative) of deep venous thrombosis or pulmonary embolism
• Receipt of liver allograft from HCV positive donor or Hepatitis B core antibody positive donor
• Receipt of liver allograft donated after cardiac death of donor
• Receipt of any antiviral agents (licensed or investigational) for hepatitis C virus within 90 days prior to enrollment
• Previous receipt of an HCV protease inhibitor
• Receipt of any other investigational study product within 30 days prior to enrollment
• Seizure disorder requiring anti-convulsant therapy
• Pulmonary arterial hypertension requiring sildenafil or tadalafil infusion
• Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the patient participating in the study or make it unlikely that the patient could complete the study