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
18 Years
70 Years
Both
Hepatitis, Viruses, Carcinoma, Hepatitis, Viral, Human, Liver Cirrhosis
Trial Information
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
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 16 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 400 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 12 weeks post-liver transplant and then at 24 weeks post-liver
transplant to demonstrate durability of effect.
Inclusion Criteria:
- Written informed consent obtained up to 4 months prior to orthotopic liver
transplantation (OLT) and reconsent every 3 months
- HCV Genotype 1 Infection.
- Subjects treated with antiviral therapy for up to and including 16 weeks prior to
OLT.
- Most recent evidence within the last 4 weeks that HCV RNA is <100 IU/mL.
- Male and female subjects (age 18-70 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 Hepatitis B Virus (HBV) test at time of 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, and/or previous participation in this study
(except for Study 988 screen failures).
- Active drug and/or alcohol abuse.
- Inability or lacking motivation to participate in the study.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Determine the efficacy of Civacir® in preventing post-transplant HCV recurrence at 12 weeks post transplant
Outcome Description:
The primary objective is to assess the effect of administering Civacir® anti-HCV immunoglobulin therapy on prevention of orthotopic liver transplant (OLT) HCV recurrence, as measured by the proportion of subjects with unquantifiable HCV RNA levels at 12 weeks post-OLT, compared to the control group (not treated with Civacir® and considered standard of care).
Outcome Time Frame:
12 weeks
Safety Issue:
No
Principal Investigator
Norah Terrault, MD, MPH
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of California, San Francisco
Authority:
United States: Food and Drug Administration
Study ID:
988
NCT ID:
NCT01804829
Start Date:
May 2013
Completion Date:
December 2014
Related Keywords:
- Hepatitis
- Viruses
- Carcinoma
- Hepatitis, Viral, Human
- Liver Cirrhosis
- HCV Liver Transplant Immunoglobulin PCR SVR
- Carcinoma
- Hepatitis
- Hepatitis A
- Hepatitis, Viral, Human
- Hepatitis C
- Liver Cirrhosis
- Fibrosis
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