Biotest 988 Civacir
Biotest 988 Civacir
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
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 Website: https://clinicaltrials.gov/show/NCT01804829
Are you Eligible? (Inclusion 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.
New York, NY 10032United States