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

NCT01121185 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2016-06-14

Study results available
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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.

Conditions

  • HCV Infection
  • Liver Transplantation

Interventions

BIOLOGICAL

MBL-HCV1

50 mg/kg MBL-HCV1, intravenous

OTHER

0.9% Sodium chloride Placebo

0.9% sodium chloride, intravenous

Sponsors & Collaborators

  • MassBiologics

    lead OTHER

Principal Investigators

  • Deborah C. Molrine, MD · Massbiologics of University of Massachusetts Medical School

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01121185 on ClinicalTrials.gov