Safety and Pharmacokinetics Study of Anthrax Immune Globulin Intravenous (AIGIV)

NCT ID: NCT00845650

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2010-10-31

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® (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).

Conditions

Anthrax

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

AIGIV 3.5 mg/kg (Cohort A)

AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.

Group Type: EXPERIMENTAL

AIGIV 3.5 mg/kg

Intervention Type: BIOLOGICAL

AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.

Gamunex 90 mg/kg (Cohort A)

Gamunex 90 mg/kg total IgG as a single intravenous infusion.

Group Type: OTHER

Gamunex 90 mg/kg

Intervention Type: BIOLOGICAL

Gamunex 90 mg/kg total IgG as a single intravenous infusion.

AIGIV 7.0 mg/kg (Cohort B)

AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.

Group Type: EXPERIMENTAL

AIGIV 7.0 mg/kg

Intervention Type: BIOLOGICAL

AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.

Gamunex 180 mg/kg (Cohort B)

Gamunex 180 mg/kg total IgG as a single intravenous infusion.

Group Type: OTHER

Gamunex 180 mg/kg

Intervention Type: BIOLOGICAL

Gamunex 180 mg/kg total IgG as a single intravenous infusion.

AIGIV 14.0 mg/kg (Cohort C)

AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.

Group Type: EXPERIMENTAL

AIGIV 14.0 mg/kg

Intervention Type: BIOLOGICAL

AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.

Gamunex 360 mg/kg (Cohort C)

Gamunex 360 mg/kg total IgG as a single intravenous infusion.

Group Type: OTHER

Gamunex 360 mg/kg

Intervention Type: BIOLOGICAL

Gamunex 360 mg/kg total IgG as a single intravenous infusion.

Interventions

AIGIV 3.5 mg/kg

AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.

Intervention Type: BIOLOGICAL

Gamunex 90 mg/kg

Gamunex 90 mg/kg total IgG as a single intravenous infusion.

Intervention Type: BIOLOGICAL

AIGIV 7.0 mg/kg

AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.

Intervention Type: BIOLOGICAL

Gamunex 180 mg/kg

Gamunex 180 mg/kg total IgG as a single intravenous infusion.

Intervention Type: BIOLOGICAL

AIGIV 14.0 mg/kg

AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.

Intervention Type: BIOLOGICAL

Gamunex 360 mg/kg

Gamunex 360 mg/kg total IgG as a single intravenous infusion.

Intervention Type: BIOLOGICAL

Other Intervention Names

human immune globulin intravenous

Eligibility Criteria

Inclusion Criteria

• Between 18 and 65 years of age, inclusive.
• Have a minimal weight of 110 lbs and a body mass index (BMI) between 17 and 35.
• In good health.
• For pre-menopausal female subjects, using acceptable methods of birth control.
• Willing and capable of complying with all aspects of the protocol through completion of the program period.
• No blood donation in the preceding 8 weeks; willing to not donate whole blood or plasma during the clinical trial; and willing to not donate whole blood or plasma for up to one year following the last infusion.
• Has read and signed an informed consent form.
• Adequate venous access and can receive intravenous infusion.

Exclusion Criteria

• Previously intolerant of immune globulin or blood product preparations or known immunodeficiency.
• Previous treatment with immune globulin products or blood products within three months of study.
• Previous receipt of anthrax vaccine, known exposure to anthrax organisms, or previously enlisted in the military.
• Receipt of any live vaccine within three months or inactivated vaccine within 2 weeks prior to study; plans to receive any vaccine at any time during the study.
• Participation in any investigational clinical trial within one month prior to study.
• Positive serology for human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus.
• Receipt of chemotherapy, radiation therapy, immunosuppressive therapy, or high-dose corticosteroid therapy within five years of study.
• Use of prohibited medications as defined in the protocol.
• History of drug or alcohol abuse within 1 year of study.
• History of IgA deficiency.
• Pregnancy.
• Positive Coombs test at screening.
• Males with a hemoglobin value less than 13.2 gm/dL and females less than 10.9 gm/dL.
• Absolute eosinophil counts greater than 600 cells/mm3 or Absolute lymphocyte counts less than 1000 cells/mm3.
• Aspartate aminotransferase (AST) >55 U/L or alanine aminotransferase (ALT) >60 U/L.
• Hyperglycemia with random blood glucose >141 mg/dL, fasting blood glucose >112 mg/dL, or urine glucose >50 mg/dL; or hypoglycemia with a blood glucose <65 mg/dL.
• BUN >25 mg/dL or creatinine, for males >1.4 mg/dL and, for females >1.2 mg/dL.
• Creatinine clearance <80 mL/min.
• Urine protein >15 mg/dL for males and non-menstruating females, or >30 mg/dL for menstruating females.
• Febrile illness within three days prior to infusion.
• History of significant medical or psychiatric condition or abnormal laboratory tests indicating possible underlying medical condition.
• An opinion of the investigator that a condition exists that would preclude compliance with protocol-specified procedures.
• Absolute neutrophil count is less than 3000 cells/mm3 as defined by the central lab (screening) or local lab (pre-infusion) for cohort B. Absolute neutrophil count is less than 2500 cells/mm3 as defined by the central lab (screening) or local lab (pre-infusion) for cohort C.
• White blood cell counts are less than 3500 cells/mm3 as defined by the central lab (screening) or local lab (pre-infusion) for cohorts B and C.
• History of a severe or anaphylactic reaction to quinolone or penicillin antibiotics.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Emergent BioSolutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohamed Al-Ibrahim, MD

Role: PRINCIPAL_INVESTIGATOR

SNBL Clinical Pharmacology Center Inc, Baltimore, MD

Robert J Hopkins, MD, MPH & TM

Role: STUDY_DIRECTOR

Emergent Product Development Gaithersburg

Locations

SNBL Clinical Pharmacology Center Inc.

Baltimore, Maryland, United States

Countries

United States

References

Mytle N, Hopkins RJ, Malkevich NV, Basu S, Meister GT, Sanford DC, Comer JE, Van Zandt KE, Al-Ibrahim M, Kramer WG, Howard C, Daczkowski N, Chakrabarti AC, Ionin B, Nabors GS, Skiadopoulos MH. Evaluation of intravenous anthrax immune globulin for treatment of inhalation anthrax. Antimicrob Agents Chemother. 2013 Nov;57(11):5684-92. doi: 10.1128/AAC.00458-13. Epub 2013 Aug 26.

Reference Type: DERIVED

PMID: 23979731 (View on PubMed)

Related Links

http://www.emergentbiosolutions.com/

Sponsor website

Other Identifiers

DMID 07-0067

Identifier Type: OTHER

Identifier Source: secondary_id

HHSN272200700034C

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

EBS.AIG.001

Identifier Type: -

Identifier Source: org_study_id