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
Description
Detailed Description
End stage liver disease secondary to Hepatitis C virus infection is the most frequent indication for liver transplantation. However, recurrence of the disease is almost universal and is the cause of increased morbidity and mortality. At this time, attempts to treat recurrence have been difficult as the treatment is difficult to tolerate and often ineffective in the post transplant setting. In this study, we hope to learn if treatment with hepatitis C immunoglobulin (Civacir) post-operatively is safe and effective in the prevention of disease recurrence. Participants will be randomized 1:1 to 300mg/kg or control. Participants will be followed out to 6 months with monitoring of hepatic function and HCV levels. Safety data will be collected through medical follow up, examinations and follow up of hepatic function. Statistical analysis will be conducted by the sponsor to determine if the drug (and dose) are effective in preventing recurrent HCV.
Phase
Phase 3Inclusion and Exclusion Criteria
- 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.
- 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.
Sites
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California
- University of Southern California / Keck Hospital, Los Angeles, California, 90033
- University of California San Francisco, San Francisco, California, 94143
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Utah
- University of Utah Health Sciences Center, Salt Lake City, Utah, 84112
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Oregon
- Oregon Health & Science University, Portland, Oregon, 97239
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Texas
- Baylor University Medical Center, Dallas, Texas, 75246
- Advanced Liver Therapies / St. Luke's Episcopal Hospital, Houston, Texas, 77030
- Houston Methodist, Houston, Texas, 77030
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Louisiana
- Ochsner Medical Center, New Orleans, Louisiana, 70121
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Illinois
- Northwestern Memorial Hospital, Chicago, Illinois, 60611
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Tennessee
- Vanderbilt University Medical Center, Nashville, Tennessee, 37232
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Kentucky
- University of Kentucky Chandler Medical Center, Lexington, Kentucky, 40536
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Georgia
- Piedmont Atlanta, Atlanta, Georgia, 30309
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