Civacir® Polyclonal Immune Globulin (IgG) to Prevent Hepatitis C Virus (HCV) Recurrence in Liver Transplant Patients.

Completed · Phase 3

Conditions studied: Hepatitis C Infection, Viruses, Hepatocellular Carcinoma, Hepatitis, Viral, Human, Liver Cirrhosis

In brief

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.

Key facts

Study ID

NCT01804829

Run by

Biotest Pharmaceuticals Corporation

People needed

80

Starts

2013-06-01

Expected to finish

2016-06-01

Last updated by the study team

2017-03-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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