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| ID | Type | Description | Link |
|---|---|---|---|
| DMID 07-0067 | Other Identifier | NIAID | |
| HHSN272200700034C | Other Grant/Funding Number | NIAID |
Not provided
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
Not provided
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The purpose of this study is to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIGIV 3.5 mg/kg (Cohort A) | Experimental | AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion. |
|
| Gamunex 90 mg/kg (Cohort A) | Other | Gamunex 90 mg/kg total IgG as a single intravenous infusion. |
|
| AIGIV 7.0 mg/kg (Cohort B) | Experimental | AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion. |
|
| Gamunex 180 mg/kg (Cohort B) | Other | Gamunex 180 mg/kg total IgG as a single intravenous infusion. |
|
| AIGIV 14.0 mg/kg (Cohort C) | Experimental | AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion. |
|
| Gamunex 360 mg/kg (Cohort C) | Other |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIGIV 3.5 mg/kg | Biological | AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Adverse Events (AEs) | Any untoward medical occurrence reported to or observed by the principal investigator (PI), including as identified from other safety assessments (eg, vital signs, clinical laboratory testing, electrocardiogram). | From the time of infusion through Day 90. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Titer/Concentration of TNA (Toxin Neutralizing Antibody) (Cmax) | Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion. Assay results are reported as the 50% neutralization factor, TNA NF50: the ED50 of the test sample (ie, effective dilution of test sample that neutralized 50% of toxin) divided by the ED50 of the reference standard. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Al-Ibrahim, MD | SNBL Clinical Pharmacology Center Inc, Baltimore, MD | Principal Investigator |
| Robert J Hopkins, MD, MPH & TM | Emergent Product Development Gaithersburg | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SNBL Clinical Pharmacology Center Inc. | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23979731 | Derived | 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. |
| Label | URL |
|---|---|
| Sponsor website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | AIGIV 3.5 mg/kg (Cohort A) | AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion. |
| FG001 | Gamunex 90 mg/kg (Cohort A) | Gamunex 90 mg/kg total IgG as a single intravenous infusion. |
| FG002 | AIGIV 7.0 mg/kg (Cohort B) | AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion. |
| FG003 | Gamunex 180 mg/kg (Cohort B) | Gamunex 180 mg/kg total IgG as a single intravenous infusion. |
| FG004 | AIGIV 14.0 mg/kg (Cohort C) | AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion. |
| FG005 | Gamunex 360 mg/kg (Cohort C) | Gamunex 360 mg/kg total IgG as a single intravenous infusion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | AIGIV 3.5 mg/kg (Cohort A) | AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion. |
| BG001 | Gamunex 90 mg/kg (Cohort A) | Gamunex 90 mg/kg total IgG as a single intravenous infusion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Reporting Adverse Events (AEs) | Any untoward medical occurrence reported to or observed by the principal investigator (PI), including as identified from other safety assessments (eg, vital signs, clinical laboratory testing, electrocardiogram). | Safety Population: all subjects who received any infusion of AIGIV or Gamunex. | Posted | Count of Participants | Participants | From the time of infusion through Day 90. |
|
From the time of infusion through Day 90.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AIGIV 3.5 mg/kg (Cohort A) | AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Emergent Product Development Gaithersburg, Inc. | clinicalstudies@ebsi.com |
Not provided
| ID | Term |
|---|---|
| D000881 | Anthrax |
| ID | Term |
|---|---|
| D016863 | Bacillaceae Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
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Gamunex 360 mg/kg total IgG as a single intravenous infusion.
|
| Gamunex 90 mg/kg | Biological | Gamunex 90 mg/kg total IgG as a single intravenous infusion. |
|
|
| AIGIV 7.0 mg/kg | Biological | AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion. |
|
| Gamunex 180 mg/kg | Biological | Gamunex 180 mg/kg total IgG as a single intravenous infusion. |
|
| AIGIV 14.0 mg/kg | Biological | AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion. |
|
| Gamunex 360 mg/kg | Biological | Gamunex 360 mg/kg total IgG as a single intravenous infusion. |
|
| From the time of infusion through Day 90 postinfusion. |
| Time of Cmax | Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion. | From the time of infusion through Day 90 postinfusion. |
| Area Under the Curve to the Last Time With a Measurable TNA Titer (AUC[0-t]) | Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion. | From the time of infusion through Day 90 postinfusion. |
| Area Under the Curve to Infinity (AUC[0-inf]) | Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion. | From the time of infusion through Day 90 postinfusion. |
| Elimination Rate Constant | Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion. | From the time of infusion through Day 90 postinfusion. |
| Elimination Half-life (t½) | Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion. | From the time of infusion through Day 90 postinfusion. |
| Mean Residence Time (MRT) | Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion. | From the time of infusion through Day 90 postinfusion. |
| Lost to Follow-up |
|
| Sponsor hold on dosing |
|
| Unable to access IV line |
|
| BG002 | AIGIV 7.0 mg/kg (Cohort B) | AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion. |
| BG003 | Gamunex 180 mg/kg (Cohort B) | Gamunex 180 mg/kg total IgG as a single intravenous infusion. |
| BG004 | AIGIV 14.0 mg/kg (Cohort C) | AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion. |
| BG005 | Gamunex 360 mg/kg (Cohort C) | Gamunex 360 mg/kg total IgG as a single intravenous infusion. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index | Count of Participants | Participants |
|
| OG002 | AIGIV 7.0 mg/kg (Cohort B) | AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion. |
| OG003 | Gamunex 180 mg/kg (Cohort B) | Gamunex 180 mg/kg total IgG as a single intravenous infusion. |
| OG004 | AIGIV 14.0 mg/kg (Cohort C) | AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion. |
| OG005 | Gamunex 360 mg/kg (Cohort C) | Gamunex 360 mg/kg total IgG as a single intravenous infusion. |
|
|
| Secondary | Maximum Plasma Titer/Concentration of TNA (Toxin Neutralizing Antibody) (Cmax) | Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion. Assay results are reported as the 50% neutralization factor, TNA NF50: the ED50 of the test sample (ie, effective dilution of test sample that neutralized 50% of toxin) divided by the ED50 of the reference standard. | Pharmacokinetic (PK) intent-to-treat (ITT) population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer. | Posted | Mean | Standard Deviation | NF50 (50% neutralization factor) | From the time of infusion through Day 90 postinfusion. |
|
|
|
| Secondary | Time of Cmax | Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion. | Pharmacokinetic ITT population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer. | Posted | Mean | Standard Deviation | hours | From the time of infusion through Day 90 postinfusion. |
|
|
|
| Secondary | Area Under the Curve to the Last Time With a Measurable TNA Titer (AUC[0-t]) | Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion. | Pharmacokinetic ITT population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer. | Posted | Mean | Standard Deviation | h*NF50 | From the time of infusion through Day 90 postinfusion. |
|
|
|
| Secondary | Area Under the Curve to Infinity (AUC[0-inf]) | Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion. | Pharmacokinetic ITT population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer. | Posted | Mean | Standard Deviation | h*NF50 | From the time of infusion through Day 90 postinfusion. |
|
|
|
| Secondary | Elimination Rate Constant | Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion. | Pharmacokinetic ITT population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer. | Posted | Mean | Standard Deviation | /h | From the time of infusion through Day 90 postinfusion. |
|
|
|
| Secondary | Elimination Half-life (t½) | Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion. | Pharmacokinetic ITT population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer. | Posted | Median | Full Range | hours | From the time of infusion through Day 90 postinfusion. |
|
|
|
| Secondary | Mean Residence Time (MRT) | Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion. | Pharmacokinetic ITT population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer. | Posted | Mean | Standard Deviation | hours | From the time of infusion through Day 90 postinfusion. |
|
|
|
| 0 |
| 30 |
| 1 |
| 30 |
| 28 |
| 30 |
| EG001 | Gamunex 90 mg/kg (Cohort A) | Gamunex 90 mg/kg total IgG as a single intravenous infusion. | 0 | 5 | 0 | 5 | 5 | 5 |
| EG002 | AIGIV 7.0 mg/kg (Cohort B) | AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion. | 0 | 31 | 1 | 31 | 29 | 31 |
| EG003 | Gamunex 180 mg/kg (Cohort B) | Gamunex 180 mg/kg total IgG as a single intravenous infusion. | 0 | 14 | 1 | 14 | 11 | 14 |
| EG004 | AIGIV 14.0 mg/kg (Cohort C) | AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion. | 0 | 29 | 0 | 29 | 29 | 29 |
| EG005 | Gamunex 360 mg/kg (Cohort C) | Gamunex 360 mg/kg total IgG as a single intravenous infusion. | 0 | 16 | 0 | 16 | 15 | 16 |
| Sepsis syndrome | Infections and infestations | Systematic Assessment |
|
| Gun shot wound | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Intra-uterine death | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Tooth disorder | Gastrointestinal disorders | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Infusion site pain | General disorders | Systematic Assessment |
|
| Infusion site reaction | General disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Vessel puncture site haematoma | General disorders | Systematic Assessment |
|
| Vessel puncture site pain | General disorders | Systematic Assessment |
|
| Bacteriuria | Infections and infestations | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Bacteria urine | Investigations | Systematic Assessment |
|
| Blood pressure decreased | Investigations | Systematic Assessment |
|
| Blood pressure increased | Investigations | Systematic Assessment |
|
| Blood urine present | Investigations | Systematic Assessment |
|
| Body temperature increased | Investigations | Systematic Assessment |
|
| Heart rate decreased | Investigations | Systematic Assessment |
|
| Heart rate increased | Investigations | Systematic Assessment |
|
| Nitrite urine | Investigations | Systematic Assessment |
|
| Protein urine | Investigations | Systematic Assessment |
|
| Respiratory rate increased | Investigations | Systematic Assessment |
|
| White blood cells urine positive | Investigations | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Trismus | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Agitation | Psychiatric disorders | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | Systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
Not provided
| D007239 | Infections |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |