Abstract

Phase I, open-label, multidose study to administer rBPI21 intravenously to patients with cystic fibrosis, using three different regimens. Cystic fibrosis patients have pathology and morbidity associated with chronic gram-negative pulmonary infections and have been shown to have elevated levels of bacterial endotoxin when experiencing bacterial exacerbations. For these reasons, rBPI21 (recombinant bactericidal/permeability increasing protein is a 21kD recombinant human protein) has been proposed as a potential agent in treating cystic fibrosis, particularly those patients with multiple drug resistant Pseudomonas infections. Primary Objective: to assess safety, pharmacokinetics, and immunogenicity of rBPI21. Secondary Objectives: to assess levels of BPI and optionally, levels of natural BPI and rBPI21 in pulmonary secretions; to assess the potential effect of rBPI21 on bacteria in the pulmonary secretions; to assess the potential effect of rBPI21 on bacterial LPS and selected inflammatory cytokines in both blood and pulmonary secretions; and to explore potential clinical efficacy endpoints.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR002172-17S2
Application #
6265644
Study Section
Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
17
Fiscal Year
1999
Total Cost
Indirect Cost

  Institution

Name
Children's Hospital Boston
Department
Type
DUNS #
076593722
City
Boston
State
MA
Country
United States
Zip Code
02115

  Publications

Cassidy, Adam R; Bernstein, Jane Holmes; Bellinger, David C et al. (2018) Visual-spatial processing style is associated with psychopathology in adolescents with critical congenital heart disease. Clin Neuropsychol :1-19
Bean Jaworski, Jessica L; White, Matthew T; DeMaso, David R et al. (2018) Visuospatial processing in adolescents with critical congenital heart disease: Organization, integration, and implications for academic achievement. Child Neuropsychol 24:451-468
Hron, Bridget M; Ebbeling, Cara B; Feldman, Henry A et al. (2017) Hepatic, adipocyte, enteric and pancreatic hormones: response to dietary macronutrient composition and relationship with metabolism. Nutr Metab (Lond) 14:44
Rollins, Caitlin K; Asaro, Lisa A; Akhondi-Asl, Alireza et al. (2017) White Matter Volume Predicts Language Development in Congenital Heart Disease. J Pediatr 181:42-48.e2
Sakai Bizmark, Rie; Chang, Ruey-Kang R; Tsugawa, Yusuke et al. (2017) Impact of AHA's 2007 guideline change on incidence of infective endocarditis in infants and children. Am Heart J 189:110-119
Selamet Tierney, Elif Seda; Hollenbeck-Pringle, Danielle; Lee, Caroline K et al. (2017) Reproducibility of Left Ventricular Dimension Versus Area Versus Volume Measurements in Pediatric Patients With Dilated Cardiomyopathy. Circ Cardiovasc Imaging 10:
Cassidy, Adam R; White, Matthew T; DeMaso, David R et al. (2016) Processing speed, executive function, and academic achievement in children with dextro-transposition of the great arteries: Testing a longitudinal developmental cascade model. Neuropsychology 30:874-885
Faden, Maheer; Holm, Mari; Allred, Elizabeth et al. (2016) Antenatal glucocorticoids and neonatal inflammation-associated proteins. Cytokine 88:199-208
Kim, So Hyun; Joseph, Robert M; Frazier, Jean A et al. (2016) Predictive Validity of the Modified Checklist for Autism in Toddlers (M-CHAT) Born Very Preterm. J Pediatr 178:101-107.e2
Leviton, Alan; Allred, Elizabeth N; Fichorova, Raina N et al. (2016) Antecedents of inflammation biomarkers in preterm newborns on days 21 and 28. Acta Paediatr 105:274-80

Showing the most recent 10 out of 463 publications