Open Label Study of the Efficacy and Safety of MBL-HCV1 in Combination With Oral Direct-Acting Antivirals in Patients Undergoing Liver Transplantation for Hepatitis C
Condition: Hepatitis C Infection
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: MBL-HCV1; Telaprevir (Part 1); Sofosbuvir (Part 2)
Intervention description: 50 mg/kg MBL-HCV1, intravenous, up to 15 infusions over 56 days; option for extended treatment through 84 days if viral load undetectable at day 56; Two 375 mg tablets, 3 times a day up to 56 days; option for extended treatment through 84 days if viral load undetectable at day 56; One 400 mg tablet, 1 time per day up to 56 days; option for extended treatment through 84 days if viral load undetectable at day 56
Intervention MeSH terms: Sofosbuvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Liver Transplantation

Summary:

      The purpose of this study is to assess efficacy of a human monoclonal antibody against
      Hepatitis C (MBL-HCV1) combined with telaprevir [part 1: an HCV protease inhibitor] or
      sofosbuvir [part 2: an Hepatitis C virus NS5B polymerase inhibitor] in a 56 day treatment
      duration in patients undergoing liver transplantation due to chronic HCV infection. There is
      an option for extended study treatment through 84 days if viral load is undetectable at day
      56.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient ≥ 18 years of age with documented chronic hepatitis C virus infection of
             genotype 1 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 30 days prior to liver transplantation, unless patient has documented
             detectable HCV RNA during this 30 day period

          -  Previous receipt of an HCV protease inhibitor (for subjects enrolling in Part 1:
             telaprevir)

          -  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 (for
             subjects enrolling in Part 1: telaprevir)

          -  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