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

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 (HCV) to prevent infection. Subjects who reduce their viral load to
less than 100 IU/ml HCV RNA through up to 24 weeks of antiviral therapy prior to liver
transplant are enrolled in the study. There is no requirement to reach undetectable virus
prior to transplant as the function of Civacir® is to neutralize any remaining virus in
circulation.

Subjects randomized to Civacir® treatment arms receive study drug infusions starting on the
day of liver transplant followed by 15 doses over a 10 week period to prevent the recurrence
of quantifiable Hepatitis C Virus (HCV) after liver transplant. The study will evaluate
dosing arms ranging from 200 mg/kg to 300 mg/kg compared to a control arm. For the primary
endpoint, efficacy is defined as persistent viral load suppression maintaining HCV RNA
levels below the lower limit of quantitation as determined by central laboratory Polymerase
Chain Reaction (PCR) at 22 weeks post-liver transplant and then at 34 weeks post-liver
transplant to demonstrate durability of effect.

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.