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Summary of Trials for Liver Transplant Patients

LIVER TRANSPLANT PATIENTS


Title: Study of Hepatitis C Virus (HCV) Infected Patients Undergoing Liver Transplantation to Evaluate a Human Monoclonal Antibody Against Hepatitis C (MBL-HCV1)

BIDMC Principal Investigator
- Transplant Hepatologist, Michael Curry, MD

Type of Study - Interventional Phase II Drug Trial

Trial Status -Closed to enrollment, follow up completed.

Sponsor - MassBiologics (MBL)

BIDMC Contact Person: Susan McDermott, RN, MPH: 617.632.9841 or smcderm2@bidmc.harvard.edu

Why Is This Study Being Done? - The purpose of this study was to determine whether a human monoclonal antibody against Hepatitis C (named MBL-HCV1) can prevent or delay recurrence of HCV or reduce the amount of detectable HCV in patients after liver transplantation.

What's Involved? - Patients with end stage liver disease caused by hepatitis C infection and listed for liver transplantation were invited to participate in the trial. Participants were randomized before transplantation surgery to receive MBL-HCV1 or placebo (inactive drug). Participants received 11 treatments of the study drug intravenously over a 14 day period starting just before their surgery. Participants completed study follow up visits including physical exams and blood studies up to Day 56 following their transplants. A liver biopsy was completed on the day of transplant and another was completed on day 42 following transplant. Study visits were scheduled to coincide with routine clinic visits whenever possible.

Find out More on the National Clinical Trials Registry: This study and other clinical trials are included in the National Clinical Trials Registry, which summarizes information about a clinical trial's purpose, who may participate, trial site locations, and contact phone numbers. Related research publications and study results are also posted to the Registry site as they become available.

Use this link to read more about this study on the National Clinical Trial Registry: http://clinicaltrials.gov/ct2/show/NCT01121185