Civacir® Polyclonal Immune Globulin (IgG) to Prevent Hepatitis C Virus (HCV) Recurrence in Liver Transplant Patients.
NCT01804829 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2017-03-15
Summary
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.
Conditions
- Hepatitis C Infection
- Viruses
- Hepatocellular Carcinoma
- Hepatitis, Viral, Human
- Liver Cirrhosis
Interventions
- BIOLOGICAL
-
Civacir® 10%
The active ingredient is Human Immunoglobulin G (IgG) which is a normal constituent purified from human source plasma containing a diversity of antibodies targeting the Hepatitis C Virus.
Sponsors & Collaborators
-
Biotest Pharmaceuticals Corporation
lead INDUSTRY
Principal Investigators
-
Norah Terrault, MD, MPH · University of California, San Francisco
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-06-30
- Primary Completion
- 2016-02-29
- Completion
- 2016-06-30
Countries
- United States
Study Locations
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