Randomized Phase II Study of Hepatitis C Immune Globulin Intravenous (Human), Civacir(TM), in Liver Transplantation
|Sequelae of Viral Hepatitis Transplantation Infection Evidence of Liver Transplantation||Biological: Hepatitis C Immune Globulin Intravenous (Human) 5%||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|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|
- Post Transplant Reduction in Viral Load (as Measured Quantitatively by Hepatitis C Virus (HCV) Reverse Transcription-Polymerase Chain Reaction (HCV RT-PCR)). [ Time Frame: Outcome evaluations at 1 month (Day 28) and 6 months ( 24 weeks) post-tranplant. ]Proportion of subjects who achieve reduction in viral load from the baseline pre-transplant value. Baseline is the pre-transplant HCV viral load as measeured by RT-PCR. Post-transplant HCV viral load is determined at both 1 month and 6 months post-tranplant.
|Study Start Date:||May 2007|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Experimental: Civacir Treated
Hepatitis C Immune Globulin Intravenous (Human) 5% [Civacir], 18 infusions total, per schedule, of Civacir 300 or 400 mg/kg of body weight, with standard post-transplant site specific routine immunosuppressant therapy .
Biological: Hepatitis C Immune Globulin Intravenous (Human) 5%
Hepatitis C Immune Globulin Intravenous (Human) 5%, [Civacir]: 18 infusions total, per schedule, of 300 or 400 mg/kg of body weight given with standard post-transplant therapy inclusive of immunosuppressive agents.
Other Name: Civacir™
No Intervention: Observational Control
Observation on standard post-transplant site specific routine immunosuppressant therapy without infusions of Hepatitis C Immune Globulin Intravenous (Human) 5% [Civacir].
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00473824
|United States, Arizona|
|Phoenix, Arizona, United States, 85054|
|United States, Florida|
|Jacksonville, Florida, United States, 32224|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Director:||Eliezer Katz, MD||Clinical Trial and Consulting Services|
|Study Director:||Shailesh Chavan, MD||Biotest Pharmaceuticals|