Status:
COMPLETED
Civacir® Polyclonal Immune Globulin (IgG) to Prevent Hepatitis C Virus (HCV) Recurrence in Liver Transplant Patients.
Lead Sponsor:
Biotest Pharmaceuticals Corporation
Conditions:
Hepatitis C Infection
Viruses
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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.
Detailed Description
Civacir® 10%, Hepatitis C Immune Globulin Intravenous (Human) is a high-titer human polyclonal immune globulin (IgG) containing a diversity of antibodies that target and bind the hepatitis C virus (HC...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01804829
Start Date
June 1 2013
End Date
June 1 2016
Last Update
March 15 2017
Active Locations (23)
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1
University of Southern California / Keck Hospital
Los Angeles, California, United States, 90033
2
University of California San Francisco
San Francisco, California, United States, 94143
3
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
4
Florida Hospital Transplant Institute
Orlando, Florida, United States, 32804