A Phase 1/2 interventional study of AIGIV 3.5 mg/kg and Gamunex 90 mg/kg in Anthrax, sponsored by Emergent BioSolutions. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-18.
Sponsored by Emergent BioSolutions · Phase 1/2, Interventional, and Treatment
The purpose of this study is to:
75 studies on the registry are indexed under Anthrax; 12 are open to participants now.
This study's enrollment of 129 is above the median of 100 across 57 interventional studies indexed under Anthrax.
Browse Anthrax studies →Emergent BioSolutions is the lead sponsor of 47 studies on the registry; 7 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 7 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
Biological: AIGIV 3.5 mg/kg
Gamunex 90 mg/kg total IgG as a single intravenous infusion.
Biological: Gamunex 90 mg/kg
AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
Biological: AIGIV 7.0 mg/kg
Gamunex 180 mg/kg total IgG as a single intravenous infusion.
Biological: Gamunex 180 mg/kg
AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
Biological: AIGIV 14.0 mg/kg
Gamunex 360 mg/kg total IgG as a single intravenous infusion.
Biological: Gamunex 360 mg/kg
AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
Drug page: Immunoglobulins, Intravenous
Gamunex 90 mg/kg total IgG as a single intravenous infusion.
Also known as: human immune globulin intravenous
AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
Drug page: Immunoglobulins, Intravenous
Gamunex 180 mg/kg total IgG as a single intravenous infusion.
AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
Drug page: Immunoglobulins, Intravenous
Gamunex 360 mg/kg total IgG as a single intravenous infusion.
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).
Time frame: From the time of infusion through Day 90.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From the time of infusion through Day 90 postinfusion.
| Milestone | AIGIV 3.5 mg/kg (Cohort A) | Gamunex 90 mg/kg (Cohort A) | AIGIV 7.0 mg/kg (Cohort B) | Gamunex 180 mg/kg (Cohort B) | AIGIV 14.0 mg/kg (Cohort C) | Gamunex 360 mg/kg (Cohort C) |
|---|---|---|---|---|---|---|
| Started | 31 | 5 | 31 | 14 | 31 | 17 |
| Completed | 30 | 5 | 28 | 13 | 28 | 15 |
| Not completed | 1 | 0 | 3 | 1 | 3 | 2 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 2 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 3 | 1 | 0 | 1 |
| Withdrew: Sponsor hold on dosing | 0 | 0 | 0 | 0 | 1 | 1 |
| Withdrew: Unable to access iv line | 1 | 0 | 0 | 0 | 0 | 0 |
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).
| Participants | AIGIV 3.5 mg/kg (Cohort A) | Gamunex 90 mg/kg (Cohort A) | AIGIV 7.0 mg/kg (Cohort B) | Gamunex 180 mg/kg (Cohort B) | AIGIV 14.0 mg/kg (Cohort C) | Gamunex 360 mg/kg (Cohort C) |
|---|---|---|---|---|---|---|
| Number of Participants Reporting Adverse Events (AEs) | 28 | 5 | 29 | 11 | 29 | 15 |
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.
| NF50 (50% neutralization factor) | AIGIV 3.5 mg/kg (Cohort A) | AIGIV 7.0 mg/kg (Cohort B) | AIGIV 14.0 mg/kg (Cohort C) |
|---|---|---|---|
| Maximum Plasma Titer/Concentration of TNA (Toxin Neutralizing Antibody) (Cmax) | 1.07 ± 0.26 | 2.21 ± 0.48 | 4.31 ± 0.98 |
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.
| hours | AIGIV 3.5 mg/kg (Cohort A) | AIGIV 7.0 mg/kg (Cohort B) | AIGIV 14.0 mg/kg (Cohort C) |
|---|---|---|---|
| Time of Cmax | 4.49 ± 13.65 | 7.81 ± 23.06 | 7.35 ± 22.53 |
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.
| h*NF50 | AIGIV 3.5 mg/kg (Cohort A) | AIGIV 7.0 mg/kg (Cohort B) | AIGIV 14.0 mg/kg (Cohort C) |
|---|---|---|---|
| Area Under the Curve to the Last Time With a Measurable TNA Titer (AUC[0-t]) | 323.03 ± 312.94 | 636.31 ± 115.17 | 1277.30 ± 186.41 |
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.
| h*NF50 | AIGIV 3.5 mg/kg (Cohort A) | AIGIV 7.0 mg/kg (Cohort B) | AIGIV 14.0 mg/kg (Cohort C) |
|---|---|---|---|
| Area Under the Curve to Infinity (AUC[0-inf]) | 329.01 ± 51.04 | 698.26 ± 117.61 | 1401.08 ± 216.62 |
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.
| /h | AIGIV 3.5 mg/kg (Cohort A) | AIGIV 7.0 mg/kg (Cohort B) | AIGIV 14.0 mg/kg (Cohort C) |
|---|---|---|---|
| Elimination Rate Constant | 0.0014 ± 0.0004 | 0.0013 ± 0.0003 | 0.0012 ± 0.0004 |
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.
| hours | AIGIV 3.5 mg/kg (Cohort A) | AIGIV 7.0 mg/kg (Cohort B) | AIGIV 14.0 mg/kg (Cohort C) |
|---|---|---|---|
| Elimination Half-life (t½) | 489.36 (301.12 to 1003.89) | 526.36 (361.11 to 870.84) | 569.98 (274.82 to 1100.34) |
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.
| hours | AIGIV 3.5 mg/kg (Cohort A) | AIGIV 7.0 mg/kg (Cohort B) | AIGIV 14.0 mg/kg (Cohort C) |
|---|---|---|---|
| Mean Residence Time (MRT) | 679.67 ± 178.07 | 694.68 ± 184.39 | 724.82 ± 175.58 |
Collected over From the time of infusion through Day 90.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AIGIV 3.5 mg/kg (Cohort A) | 0/30 (0%) | 1/30 (3.3%) | 28/30 (93.3%) |
| Gamunex 90 mg/kg (Cohort A) | 0/5 (0%) | 0/5 (0%) | 5/5 (100%) |
| AIGIV 7.0 mg/kg (Cohort B) | 0/31 (0%) | 1/31 (3.2%) | 29/31 (93.5%) |
| Gamunex 180 mg/kg (Cohort B) | 0/14 (0%) | 1/14 (7.1%) | 11/14 (78.6%) |
| AIGIV 14.0 mg/kg (Cohort C) | 0/29 (0%) | 0/29 (0%) | 29/29 (100%) |
| Gamunex 360 mg/kg (Cohort C) | 0/16 (0%) | 0/16 (0%) | 15/16 (93.8%) |
| Event | AIGIV 3.5 mg/kg (Cohort A) | Gamunex 90 mg/kg (Cohort A) | AIGIV 7.0 mg/kg (Cohort B) | Gamunex 180 mg/kg (Cohort B) | AIGIV 14.0 mg/kg (Cohort C) | Gamunex 360 mg/kg (Cohort C) |
|---|---|---|---|---|---|---|
| Sepsis syndromeInfections and infestations | 0/30 | 0/5 | 0/31 | 1/14 | 0/29 | 0/16 |
| Gun shot woundInjury, poisoning and procedural complications | 0/30 | 0/5 | 0/31 | 1/14 | 0/29 | 0/16 |
| Abdominal painGastrointestinal disorders | 1/30 | 0/5 | 0/31 | 0/14 | 0/29 | 0/16 |
| Intra-uterine deathPregnancy, puerperium and perinatal conditions | 0/30 | 0/5 | 1/31 | 0/14 | 0/29 | 0/16 |
| Event | AIGIV 3.5 mg/kg (Cohort A) | Gamunex 90 mg/kg (Cohort A) | AIGIV 7.0 mg/kg (Cohort B) | Gamunex 180 mg/kg (Cohort B) | AIGIV 14.0 mg/kg (Cohort C) | Gamunex 360 mg/kg (Cohort C) |
|---|---|---|---|---|---|---|
| Blood pressure increasedInvestigations | 17/30 | 3/5 | 20/31 | 5/14 | 19/29 | 7/16 |
| Respiratory rate increasedInvestigations | 10/30 | 0/5 | 6/31 | 6/14 | 18/29 | 8/16 |
| HeadacheNervous system disorders | 5/30 | 2/5 | 10/31 | 3/14 | 10/29 | 3/16 |
| Vessel puncture site haematomaGeneral disorders | 0/30 | 0/5 | 3/31 | 1/14 | 6/29 | 5/16 |
| NeutropeniaBlood and lymphatic system disorders | 8/30 | 1/5 | 1/31 | 1/14 | 1/29 | 0/16 |
| Heart rate decreasedInvestigations | 1/30 | 0/5 | 2/31 | 0/14 | 7/29 | 2/16 |
| BradycardiaCardiac disorders | 7/30 | 0/5 | 3/31 | 2/14 | 2/29 | 0/16 |
| Heart rate increasedInvestigations | 0/30 | 0/5 | 7/31 | 1/14 | 4/29 | 3/16 |
| TachycardiaCardiac disorders | 6/30 | 1/5 | 0/31 | 0/14 | 3/29 | 0/16 |
| ContusionInjury, poisoning and procedural complications | 0/30 | 1/5 | 0/31 | 0/14 | 0/29 | 0/16 |
| Age, Continuous(years) | AIGIV 3.5 mg/kg (Cohort A) | Gamunex 90 mg/kg (Cohort A) | AIGIV 7.0 mg/kg (Cohort B) | Gamunex 180 mg/kg (Cohort B) | AIGIV 14.0 mg/kg (Cohort C) | Gamunex 360 mg/kg (Cohort C) | Total |
|---|---|---|---|---|---|---|---|
| Mean | 35.1 ± 10.3 | 35.2 ± 13.8 | 32.1 ± 10.6 | 37.1 ± 9.4 | 33.3 ± 9.1 | 36.6 ± 9.8 | 34.3 ± 10.0 |
| Age, Customized(Participants) | AIGIV 3.5 mg/kg (Cohort A) | Gamunex 90 mg/kg (Cohort A) | AIGIV 7.0 mg/kg (Cohort B) | Gamunex 180 mg/kg (Cohort B) | AIGIV 14.0 mg/kg (Cohort C) | Gamunex 360 mg/kg (Cohort C) | Total |
|---|---|---|---|---|---|---|---|
| 18 to < 30 years | 12 | 2 | 16 | 3 | 13 | 4 | 50 |
| 30 to < 40 years | 7 | 1 | 7 | 6 | 7 | 8 | 36 |
| 40 to < 50 years | 9 | 1 | 6 | 3 | 11 | 3 | 33 |
| ≥ 50 years | 3 | 1 | 2 | 2 | 0 | 2 | 10 |
| Sex: Female, Male(Participants) | AIGIV 3.5 mg/kg (Cohort A) | Gamunex 90 mg/kg (Cohort A) | AIGIV 7.0 mg/kg (Cohort B) | Gamunex 180 mg/kg (Cohort B) | AIGIV 14.0 mg/kg (Cohort C) | Gamunex 360 mg/kg (Cohort C) | Total |
|---|---|---|---|---|---|---|---|
| Female | 10 | 2 | 13 | 5 | 17 | 10 | 57 |
| Male | 21 | 3 | 18 | 9 | 14 | 7 | 72 |
| Ethnicity (NIH/OMB)(Participants) | AIGIV 3.5 mg/kg (Cohort A) | Gamunex 90 mg/kg (Cohort A) | AIGIV 7.0 mg/kg (Cohort B) | Gamunex 180 mg/kg (Cohort B) | AIGIV 14.0 mg/kg (Cohort C) | Gamunex 360 mg/kg (Cohort C) | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 0 | 2 | 3 | 2 | 8 |
| Not Hispanic or Latino | 30 | 5 | 31 | 12 | 28 | 15 | 121 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | AIGIV 3.5 mg/kg (Cohort A) | Gamunex 90 mg/kg (Cohort A) | AIGIV 7.0 mg/kg (Cohort B) | Gamunex 180 mg/kg (Cohort B) | AIGIV 14.0 mg/kg (Cohort C) | Gamunex 360 mg/kg (Cohort C) | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 1 | 0 | 1 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 26 | 2 | 16 | 7 | 16 | 9 | 76 |
| White | 5 | 3 | 14 | 5 | 12 | 6 | 45 |
| More than one race | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 2 | 1 | 2 | 5 |
| Body Mass Index(Participants) | AIGIV 3.5 mg/kg (Cohort A) | Gamunex 90 mg/kg (Cohort A) | AIGIV 7.0 mg/kg (Cohort B) | Gamunex 180 mg/kg (Cohort B) | AIGIV 14.0 mg/kg (Cohort C) | Gamunex 360 mg/kg (Cohort C) | Total |
|---|---|---|---|---|---|---|---|
| < 25 kg/m^2 | 10 | 1 | 11 | 3 | 9 | 7 | 41 |
| ≥ 25 kg/m^2 | 21 | 4 | 20 | 11 | 22 | 10 | 88 |
The record gives a start of Feb 2009, a primary completion of Oct 2010 and a completion of Oct 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2018, 7 years 8 months after primary completion. A results delay was requested in Nov 2012.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Immunoglobulins, Intravenous