Civacir® Polyclonal Immune Globulin (IgG) to Prevent Hepatitis C Virus (HCV) Recurrence in Liver Transplant Patients.
NCT ID: NCT01804829
Last Updated: 2017-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
80 participants
INTERVENTIONAL
2013-06-30
2016-06-30
Brief Summary
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Detailed Description
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Subjects randomized to Civacir® treatment arms receive study drug infusions starting on the day of liver transplant followed by 15 doses over a 10 week period to prevent the recurrence of quantifiable Hepatitis C Virus (HCV) after liver transplant. The study will evaluate dosing arms ranging from 200 mg/kg to 300 mg/kg compared to a control arm. For the primary endpoint, efficacy is defined as persistent viral load suppression maintaining HCV RNA levels below the lower limit of quantitation as determined by central laboratory Polymerase Chain Reaction (PCR) at 22 weeks post-liver transplant and then at 34 weeks post-liver transplant to demonstrate durability of effect.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Observational Control
Subjects who attain HCV RNA \<100 IU/ml and are randomized to the control arm will receive standard post-transplant immunosuppressant therapy and be followed for a 34 week period.
No interventions assigned to this group
Civacir® 10% at 200 mg/kg dose
Subjects who attain HCV RNA \<100 IU/ml and are randomized to the Civacir 200 mg/kg treatment arm will receive Civacir® before liver transplant, followed by 15 infusions over a 10 week regimen, with standard post-transplant immunosuppressant therapy. Civacir® treated subjects will be followed up to 34 weeks post-transplant.
Civacir® 10%
The active ingredient is Human Immunoglobulin G (IgG) which is a normal constituent purified from human source plasma containing a diversity of antibodies targeting the Hepatitis C Virus.
Civacir® 10% at 300 mg/kg dose
Subjects who attain HCV RNA \<100 IU/ml and are randomized to the Civacir® 300 mg/kg treatment arm will receive Civacir® before liver transplant, followed by 15 infusions over a 10 week regimen, with standard post-transplant immunosuppressant therapy. Civacir® treated subjects will be followed up to 34 weeks post-transplant.
Civacir® 10%
The active ingredient is Human Immunoglobulin G (IgG) which is a normal constituent purified from human source plasma containing a diversity of antibodies targeting the Hepatitis C Virus.
Interventions
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Civacir® 10%
The active ingredient is Human Immunoglobulin G (IgG) which is a normal constituent purified from human source plasma containing a diversity of antibodies targeting the Hepatitis C Virus.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HCV Genotype 1 through 6 Infection.
* Subjects in the beginning of a new antiviral therapy regimen (regardless of prior treatment failures) for up to and including 24 weeks prior to the day of OLT.
* Most recent evidence within the last 4 weeks that HCV RNA is \<100 IU/mL. Subjects may be randomized based on local lab HCV RNA.
* Male and female subjects (age 18-80 years).
* Subject weight under 250 pounds.
* Stable patient in a condition which in the opinion of the investigator would permit safe participation in the study.
Exclusion Criteria
* Positive HIV or HBV test within 90 days prior to transplantation.
* Most recent PCR test indicating HCV RNA ≥100 IU/mL within 4 weeks of OLT.
* Subjects having received organs from HCV positive donors.
* Serum creatinine level \>2.5 times the upper limit of normal or advanced renal disease at screening.
* Pregnancy or single contraceptive measure or lactation period (females only).
* Known intolerance to immunoglobulins or comparable substances (e.g. vaccination reaction).
* Known absolute Immunoglobulin A (IgA) deficiency.
* Known intolerance to proteins of human origin.
* Participation in another clinical trial within 90 days before signing Informed Consent Form (ICF) or during the study (observational/ non-interventional and 988 studies allowed), and/or previous participation in 988 study (except for Study 988 screen failures).
* Active drug and/or alcohol abuse.
* Inability or lacking motivation to participate in the study.
18 Years
80 Years
ALL
No
Sponsors
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Biotest Pharmaceuticals Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Norah Terrault, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of Southern California / Keck Hospital
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Florida Hospital Transplant Institute
Orlando, Florida, United States
Piedmont Hospital
Atlanta, Georgia, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Lahey Hospital
Burlington, Massachusetts, United States
NYU Langone Medical Center
New York, New York, United States
The Mount Sinai Medical Center
New York, New York, United States
Columbia University College of Physicians and Surgeons
New York, New York, United States
Oregon Health & Science University
Portland, Oregon, United States
Methodist University Hospital
Memphis, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
Advanced Liver Therapies / St. Luke's Episcopal Hospital
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Houston Methodist
Houston, Texas, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Countries
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References
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Everson GT, Terrault NA, Lok AS, Rodrigo del R, Brown RS Jr, Saab S, Shiffman ML, Al-Osaimi AM, Kulik LM, Gillespie BW, Everhart JE; Adult-to-Adult Living Donor Liver Transplantation Cohort Study. A randomized controlled trial of pretransplant antiviral therapy to prevent recurrence of hepatitis C after liver transplantation. Hepatology. 2013 May;57(5):1752-62. doi: 10.1002/hep.25976. Epub 2013 Jan 17.
Davis GL, Nelson DR, Terrault N, Pruett TL, Schiano TD, Fletcher CV, Sapan CV, Riser LN, Li Y, Whitley RJ, Gnann JW Jr; Collaborative Antiviral Study Group. A randomized, open-label study to evaluate the safety and pharmacokinetics of human hepatitis C immune globulin (Civacir) in liver transplant recipients. Liver Transpl. 2005 Aug;11(8):941-9. doi: 10.1002/lt.20405.
Other Identifiers
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988
Identifier Type: -
Identifier Source: org_study_id
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