Biotest 988 Civacir

Protocol: 
988
Phase: 
III

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)

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.

Exclusion Criteria:

  • 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.

Specialty Area(s)

Trial Location

NYP/Columbia
New York, NY 10032
United States