Civacir® Polyclonal Immune Globulin (IgG) to Prevent Hepatitis C Virus (HCV) Recurrence in Liver Transplant Patients.
A Multi-Center, Randomized, Prospective, Open-Label Phase III Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Hepatitis C Immune Globulin Intravenous (Human), Civacir®, in Orthotopic Liver Transplant Recipients
1 other identifier
interventional
80
1 country
23
Brief Summary
The purpose of this study is to test the safety and efficacy of Civacir® to prevent the recurrence of Hepatitis C Virus (HCV) after liver transplant.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2013
Typical duration for phase_3
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2013
CompletedFirst Posted
Study publicly available on registry
March 5, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedMarch 15, 2017
March 1, 2017
2.7 years
March 4, 2013
March 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the efficacy of Civacir® in preventing post-transplant HCV recurrence at 22 weeks post transplant
The primary objective is to assess the effect of administering Civacir® anti-HCV immunoglobulin therapy on prevention of orthotopic liver transplant (OLT) HCV recurrence, as measured by the proportion of subjects with unquantifiable HCV RNA levels at 22 weeks post-OLT, compared to the control group (not treated with Civacir® and considered standard of care).
22 weeks
Secondary Outcomes (1)
Determine the efficacy of Civacir® in preventing post-transplant HCV recurrence at 4 and 34 weeks post transplant
34 weeks
Other Outcomes (3)
Determine the biochemical response of Civacir® in preventing post-transplant HCV recurrence at 22 and 34 weeks post transplant
34 weeks
Evaluate the safety of Civacir® in preventing post-transplant HCV recurrence up to 34 weeks post transplant
34 weeks
Evaluate the pharmacokinetics of Civacir® up to 34 weeks post transplant
34 weeks
Study Arms (3)
Observational Control
NO INTERVENTIONSubjects 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.
Civacir® 10% at 200 mg/kg dose
EXPERIMENTALSubjects 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% at 300 mg/kg dose
EXPERIMENTALSubjects 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Written informed consent obtained prior to any study-specific assessments and within 3 months (reconsent) of orthotopic liver transplantation (OLT).
- 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.
You may not qualify if:
- Re-transplantation due to viral recurrence.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
University of Southern California / Keck Hospital
Los Angeles, California, 90033, United States
University of California San Francisco
San Francisco, California, 94143, United States
University of Miami Miller School of Medicine
Miami, Florida, 33136, United States
Florida Hospital Transplant Institute
Orlando, Florida, 32804, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Lahey Hospital
Burlington, Massachusetts, 01805, United States
NYU Langone Medical Center
New York, New York, 10016, United States
The Mount Sinai Medical Center
New York, New York, 10029, United States
Columbia University College of Physicians and Surgeons
New York, New York, 10032, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Methodist University Hospital
Memphis, Tennessee, 38104, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Advanced Liver Therapies / St. Luke's Episcopal Hospital
Houston, Texas, 77030, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Houston Methodist
Houston, Texas, 77030, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, 84112, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Related Publications (2)
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.
PMID: 22821361BACKGROUNDDavis 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.
PMID: 16035063BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Norah Terrault, MD, MPH
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2013
First Posted
March 5, 2013
Study Start
June 1, 2013
Primary Completion
February 1, 2016
Study Completion
June 1, 2016
Last Updated
March 15, 2017
Record last verified: 2017-03