Study in Hepatitis C Virus (HCV) Infected Patients Undergoing Liver Transplantation to Evaluate a Human Monoclonal Antibody Against Hepatitis C
Condition: HCV Infection; Liver Transplantation
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: MBL-HCV1; 0.9% Sodium chloride Placebo
Intervention description: 50 mg/kg MBL-HCV1, intravenous; 0.9% sodium chloride, intravenous
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C virus (HCV); Liver transplantation; Human Monoclonal Antibody

Summary:

      The purpose of this study is to determine whether a human monoclonal antibody against
      Hepatitis C (MBL-HCV1) is effective in preventing detectable levels of Hepatitis C virus in
      patients undergoing liver transplantation due to chronic HCV infection. The study will also
      determine if MBL-HCV1 is effective in delaying or reducing the amount of detectable HCV in
      patients after transplant.
    

Eligibility criteria:

        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 serology 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

          -  History of extrahepatic malignancy and/or receiving chemotherapy within 90 days prior
             to enrollment with the exception of chemoembolization for hepatocellular carcinoma

          -  Hepatocellular carcinoma with tumor burden outside of the Milan criteria

          -  History of chronic renal insufficiency or creatinine > 2.5 for ≥ six months

          -  Personal or family history 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

          -  Receipt of any other investigational study product within 30 days prior to enrollment

          -  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