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



Status:Completed
Conditions:Liver Cancer, Cancer, Gastrointestinal, Hepatitis
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases, Oncology
Healthy:No
Age Range:18 - 80
Updated:3/16/2017
Start Date:June 2013
End Date:June 2016

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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.

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.
We found this trial at
23
sites
6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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630 W 168th St
New York, New York 10032
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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1968 Peachtree Rd NW
Atlanta, Georgia 30309
(404) 605-5000
Piedmont Hospital For more than a century, Piedmont Healthcare has been a recognized leader in...
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Burlington, Massachusetts 01805
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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Houston, Texas 77030
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Memphis, Tennessee 38104
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1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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New York, New York 10016
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Orlando, Florida 32804
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Salt Lake City, Utah 84132
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San Francisco, California 94143
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