A Multi-Center, Randomized, Prospective, Open-Label Phase III Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Hepatitis C Immune Globulin (HCIG), in Orthotopic Liver Transplant Recipients
Study for liver transplant recipients using drug (IgG) to prevent Hepatitis C virus (HCV) recurrence
Sponsor: Biotest Pharmaceuticals Corporation
Enrolling: Male and Female Patients
IRB Number: AAAL8001
U.S. Govt. ID: NCT01804829
Contact: Theresa Lukose: 212-305-3839 / tt2103@columbia.edu
Additional Study Information: The purpose of this study is to test the safety of different doses of HCIG when given to patients with HCV who receive a liver transplant. It will also provide information about whether HCIG can prevent HCV infection. Participation in the study is expected to last about 10 months. Participants will be randomly assigned to either receive HCIG or not. Your participation will involve your time during your hospital stay and after discharge from the hospital. After your discharge from the hospital you will be asked to return to the clinical site for study visits. There are up to 16 visits after discharge depending on when you are discharged from the hospital. After the last infusion (Week 10) you will be asked to return at Weeks 12, 14, 16, 22 and 34 after your liver transplant to check your health status. Visits can last from less than one hour, to up to four hours.
This study is closed
Elizabeth Verna, MD
Do You Qualify?
Do you weight under 250 pounds? Yes No
Do you have Hepatitis C Virus? Yes No
You may be eligible for this study

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For more information, please contact:
Theresa Lukose