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Randomized Phase II Study of Hepatitis C Immune Globulin Intravenous (Human), Civacir(TM), in Liver Transplantation

NCT00473824 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2021-07-30

Study results available
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Summary

A Phase 2 study to evaluate safety, pharmacokinetics and efficacy of Hepatitis C Immune Globulin Intravenous (human) \[Civacir(TM)\] for preventing or reducing the impact of recurrent HCV infection following liver transplantation.

Conditions

  • Sequelae of Viral Hepatitis
  • Transplantation Infection
  • Evidence of Liver Transplantation

Interventions

BIOLOGICAL

Hepatitis C Immune Globulin Intravenous (Human) 5%

Hepatitis C Immune Globulin Intravenous (Human) 5%, \[Civacir\]: 18 infusions total, per schedule, of 300 or 400 mg/kg of body weight given with standard post-transplant therapy inclusive of immunosuppressive agents.

Sponsors & Collaborators

  • ADMA Biologics, Inc.

    lead INDUSTRY

Principal Investigators

  • Eliezer Katz, MD · Clinical Trial and Consulting Services

  • Shailesh Chavan, MD · Biotest Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00473824 on ClinicalTrials.gov