NCT00473824

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

A Randomized, Open-Label Phase II Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Hepatitis C Immune Globulin Intravenous (Human), Civacir(TM), in Liver Transplant Recipients

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: ADMA Biologics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Hepatitis C virus (HCV) infection is the leading single cause of liver transplantation (LT) in the US and Europe. Recurrence of HCV infection following LT is almost universal. There is currently no effective way to prevent post-transplantation HCV infection of the liver graft and related progression of HCV-related liver disease. This study is designed to evaluate a polyclonal human hepatitis C immune globulin (Civacir) given during and post liver transplantation for preventing or reducing the impact of recurrent HCV infection. In this open-label trial, 2 subjects will be randomized to receive Civacir (standard of care treatment plus Civacir) for every 1 Control subject (standard of care treatment alone). Civacir recipients will receive 18 intravenous infusions over 24 weeks beginning at the time of liver transplantation. Viral loads, liver enzyme assessments and liver biopsy assessments will be made at scheduled intervals during the study which will last for 48 weeks.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-05-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2007-05-16
• Last updated: 2021-07-30
• Results posted: 2012-02-07

Locations

3 sites across 1 country: United States