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Sponsored by: |
Biotest Pharmaceuticals Corporation |
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Information provided by: | Biotest Pharmaceuticals Corporation |
ClinicalTrials.gov Identifier: | NCT00473824 |
A Phase 2 study to evaluate safety, pharmacokinetics and efficacy of Hepatitis C Immune Globulin Intravenous (human) [Civacir(TM)] for preventing or reducing the impact of recurrent HCV infection following liver transplantation.
Condition | Intervention | Phase |
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Hepatitis C Virus Liver Transplantation |
Biological: Hepatitis C Immune Globulin Intravenous (Human) 5% Biological: observational control |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Open-Label Phase II Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Hepatitis C Immune Globulin Intravenous (Human), Civacir(TM), in Liver Transplant Recipients |
Estimated Enrollment: | 30 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Hepatitis C Immune Globulin Intravenous (Human) 5% [Civacir], 18 infusions total, per schedule, of Civacir 300 or 400 mg/kg of body weight
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Biological: Hepatitis C Immune Globulin Intravenous (Human) 5%
Hepatitis C Immune Globulin Intravenous (Human) 5%: 18 infusions total, per schedule, of 300 or 400 mg/kg of body weight
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2: No Intervention
Observation on standard therapy without infusions of Hepatitis C Immune Globulin Intravenous (Human) 5%
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Biological: observational control
standard therapy without Hepatitis C immune globulin infusions
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Hepatitis C virus (HCV) infection is the leading single cause of liver transplantation (LT) in the US and Europe. Recurrence of HCV infection following LT is almost universal. There is currently no effective way to prevent post-transplantation HCV infection of the liver graft and related progression of HCV-related liver disease. This study is designed to evaluate a polyclonal human hepatitis C immune globulin (Civacir) given during and post liver transplantation for preventing or reducing the impact of recurrent HCV infection.
In this open-label trial, 2 subjects will be randomized to receive Civacir (standard of care treatment plus Civacir) for every 1 Control subject (standard of care treatment alone). Civacir recipients will receive 18 intravenous infusions over 24 weeks beginning at the time of liver transplantation.
Viral loads, liver enzyme assessments and liver biopsy assessments will be made at scheduled intervals during the study which will last for 48 weeks.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Mayo Clinic | |
Phoenix, Arizona, United States | |
United States, District of Columbia | |
Georgetown University Hospital | |
Washington, District of Columbia, United States | |
United States, Florida | |
Mayo Clinic | |
Jacksonville, Florida, United States | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States |
Study Director: | Eliezer Katz, MD | Clinical Trial and Consulting Services |
Study Director: | George Herrera, MD | Biotest Pharmaceuticals |
Responsible Party: | Biotest Pharmaceuticals ( George L. Herrera, M.D., Medical Affairs Director ) |
Study ID Numbers: | Nabi-3104 |
Study First Received: | May 14, 2007 |
Last Updated: | June 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00473824 History of Changes |
Health Authority: | United States: Food and Drug Administration |
hepatitis C liver transplantation immune globulin |
Virus Diseases Hepatitis Antibodies Liver Diseases Digestive System Diseases Immunologic Factors |
Immunoglobulins, Intravenous Rho(D) Immune Globulin Hepatitis, Viral, Human Hepatitis C Immunoglobulins |
Liver Diseases RNA Virus Infections Flaviviridae Infections Immunologic Factors Physiological Effects of Drugs Hepatitis, Viral, Human Pharmacologic Actions Hepatitis |
Virus Diseases Antibodies Digestive System Diseases Immunoglobulins, Intravenous Rho(D) Immune Globulin Hepatitis C Immunoglobulins |