This was a phase I, blinded cross-over evaluation of two new intravenous gammaglobulin preparations that have been treated with solvent and detergent to reduce the risk of transmitting viral infections. The study consisted of a single infusion of either the standard 5% Gamimune or the 5% solvent/detergent preparation followed by an infusion of the alternate preparation. These infusions were followed by a blinded crossover using 10% Gamimune-N and 10% solvent/detergent treated gammaglobulin. All patients returned for a fifth infusion of their usual licensed preparation so that blood counts and chemistries could be obtained at exit. All patients were treated with the same dose and schedule that they followed prior to the study. The safety of the preparations was assessed by recording clinical reactions during or within 24 hours of the infusions and by measuring a panel of blood chemistries and blood counts. In addition, the half-life of the gammaglobulin was determined by measuring levels at several time points between infusions. A total of 7 patients were enrolled in this study at this site, for a total of 35 visits. All were males over 12 years of age with either X-linked or Common Variable Agammaglobulinemia. Six were Caucasian and one American Indian. There were no clinical or laboratory abnormalities during this study which is now closed.
| Askie, Lisa M; Darlow, Brian A; Finer, Neil et al. (2018) Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA 319:2190-2201 |
| Srinivasan, Lakshmi; Page, Grier; Kirpalani, Haresh et al. (2017) Genome-wide association study of sepsis in extremely premature infants. Arch Dis Child Fetal Neonatal Ed 102:F439-F445 |
| Denson, Lee A; McDonald, Scott A; Das, Abhik et al. (2017) Early Elevation in Interleukin-6 is Associated with Reduced Growth in Extremely Low Birth Weight Infants. Am J Perinatol 34:240-247 |
| James, Jennifer; Munson, David; DeMauro, Sara B et al. (2017) Outcomes of Preterm Infants following Discussions about Withdrawal or Withholding of Life Support. J Pediatr 190:118-123.e4 |
| Younge, Noelle; Goldstein, Ricki F; Bann, Carla M et al. (2017) Survival and Neurodevelopmental Outcomes among Periviable Infants. N Engl J Med 376:617-628 |
| Archer, Stephanie Wilson; Carlo, Waldemar A; Truog, William E et al. (2016) Improving publication rates in a collaborative clinical trials research network. Semin Perinatol 40:410-417 |
| Ahmed, Zuhayer; Prasad, Indrajit; Rahman, Hafizur et al. (2016) A Male with Extreme Subcutaneous Insulin Resistance: A Case Report. Rom J Diabetes Nutr Metab Dis 23:209-213 |
| Phelps, Dale L; Ward, Robert M; Williams, Rick L et al. (2016) Safety and pharmacokinetics of multiple dose myo-inositol in preterm infants. Pediatr Res 80:209-17 |
| Barroso, Julie; Leserman, Jane; Harmon, James L et al. (2015) Fatigue in HIV-Infected People: A Three-Year Observational Study. J Pain Symptom Manage 50:69-79 |
| Stafford-Smith, Mark; Li, Yi-Ju; Mathew, Joseph P et al. (2015) Genome-wide association study of acute kidney injury after coronary bypass graft surgery identifies susceptibility loci. Kidney Int 88:823-32 |
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