Study in Hepatitis C Virus (HCV) Infected Patients Undergoing Liver Transplantation to Evaluate a Human Monoclonal Antibody Against Hepatitis C

Stopped early · Phase 2 · Has a placebo group

Conditions studied: HCV Infection, Liver Transplantation

In brief

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.

Key facts

Study ID

NCT01121185

Run by

MassBiologics

People needed

13

Starts

2010-06-01

Expected to finish

2011-06-01

Last updated by the study team

2016-06-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Yale-New Haven Hospital — New Haven, Connecticut, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Mount Sinai Hospital — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Methodist Healthcare Foundation — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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