Clinical Trial: Safety and Pharmacokinetics Study of Anthrax Immune Globulin Intravenous (AIGIV)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Double-Blind, Dose-Escalation Study Evaluating Pharmacokinetics and Safety of Anthrax Immune Globulin Intravenous (AIGIV)
Brief Summary:
The purpose of this study is to:
- evaluate the safety profile of a single intravenous administration of AIGIV (containing either 3.5 mg/kg, 7.0 mg/kg or 14.0 mg/kg anti-PA IgG) as compared with either 90 mg/kg, 180 mg/kg or 360 mg/kg total IgG, GAMUNEX(R)(immune globulin intravenous (human) 10% caprylate/chromatography purified). GAMUNEX is a trademark of Talecris Biotherapeutics.
- evaluate the pharmacokinetic (PK) profile of a single intravenous administration of AIGIV (containing either 3.5 mg/kg, 7.0 mg/kg or 14.0 mg/kg anti-PA IgG) as measured by lethal toxin neutralizing antibody (TNA).
Detailed Summary:
Sponsor: Emergent BioSolutions
Current Primary Outcome: Adverse events [ Time Frame: pre-infusion, infusion, 5 minutes, 30 minutes, 8, 24, and 48 hours following infusion and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 following infusion. ]
Original Primary Outcome: Adverse events [ Time Frame: pre-infusion, 5 minutes, 8, 24, and 48 hours following infusion and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 following the last infusion. ]
Current Secondary Outcome:
- TNA (toxin neutralizing antibody) [ Time Frame: pre-infusion, 5 minutes, 8, 24, and 48 hours following infusion and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 following infusion. ]
- Viral serology testing, including HBsAg, Anti-HCV, Anti-HIV-1/-2/-O, Anti-HAV Total, Anti-HBc IgM and Anti-HBc total [ Time Frame: 7-28 days before infusion and Day 90 (last visit) ]
- Complete blood count (CBC) with differential [ Time Frame: 7 - 28 days before infusion, pre-infusion day, infusion day (before infusion), 8, 24, 48 hours and 5, 14, 45 days after infusion ]
- Serum Chemistry [ Time Frame: 7 - 28 days before infusion, 8, 24, 48 hours and 5, 14, 45 days after infusion ]
- Direct Coombs, haptoglobin, free hemoglobin and urine hemosiderin [ Time Frame: pre-infusion, 8, 24, 48 hours and 5 days after infusion ]
- Urinalysis [ Time Frame: 7 - 28 days before infusion, 8, 24, 48 hours and 5, 14, 45 days after infusion ]
Original Secondary Outcome:
- TNA (toxin neutralizing antibody) [ Time Frame: pre-infusion, 5 minutes, 8, 24, and 48 hours following infusion and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 following the last infusion. ]
- Viral serology testing, including HBsAg, Anti-HCV, Anti-HIV-1/-2/-O, Anti-HAV Total, Anti-HBc IgM and Anti-HBc total [ Time Frame: 7-28 days before infusion and Day 90 (last visit) ]
- Complete blood count (CBC) with differential [ Time Frame: 7 - 28 days before infusion, 8, 24, 48 hours and 5, 14, 45 days after infusion ]
- Serum Chemistry [ Time Frame: 7 - 28 days before infusion, 8, 24, 48 hours and 5, 14, 45 days after infusion ]
- Hematology [ Time Frame: preinfusion, 8, 24, 48 hours and 5 days after infusion ]
- Urinalysis [ Time Frame: 7 - 28 days before infusion, 8, 24, 48 hours and 5, 14, 45 days after infusion ]
Information By: Emergent BioSolutions
Dates:
Date Received: February 13, 2009
Date Started: February 2009
Date Completion:
Last Updated: November 21, 2012
Last Verified: November 2012