Abstract

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The study described in this protocol is an open-label, single arm trial which will evaluate the long-term safety and tolerability of ALTU-135 treatment in patients with CF-related exocrine PI. The study will be conducted at multiple CF centers and each patient will participate for 12 months. Approximately 200 male and female patients with CF-related exocrine PI will be enrolled into the study, including at least 20 children ages 7-11 years. Assuming a withdrawal rate of 20% during the first 6 months and 20% during the second 6 months, 160 patients will complete 6 months of the study and 128 patients will complete the full 1-year.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000082-47
Application #
7950758
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2008-12-01
Project End
2009-07-31
Budget Start
2008-12-01
Budget End
2009-07-31
Support Year
47
Fiscal Year
2009
Total Cost
$2,224
Indirect Cost

  Institution

Name
University of Florida
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
969663814
City
Gainesville
State
FL
Country
United States
Zip Code
32611

  Publications

Mangal, Naveen; James, Margaret O; Stacpoole, Peter W et al. (2018) Model Informed Dose Optimization of Dichloroacetate for the Treatment of Congenital Lactic Acidosis in Children. J Clin Pharmacol 58:212-220
Boissoneault, Jeff; Letzen, Janelle; Lai, Song et al. (2016) Abnormal resting state functional connectivity in patients with chronic fatigue syndrome: an arterial spin-labeling fMRI study. Magn Reson Imaging 34:603-8
Shumyak, Stepan; Yang, Li-Jun; Han, Shuhong et al. (2016) ""Lupoid hepatitis"" in SLE patients and mice with experimental lupus. Clin Immunol 172:65-71
Hendeles, Leslie; Khan, Yasmeen R; Shuster, Jonathan J et al. (2015) Omalizumab therapy for asthma patients with poor adherence to inhaled corticosteroid therapy. Ann Allergy Asthma Immunol 114:58-62.e2
Price, Catherine C; Levy, Shellie-Anne; Tanner, Jared et al. (2015) Orthopedic Surgery and Post-Operative Cognitive Decline in Idiopathic Parkinson's Disease: Considerations from a Pilot Study. J Parkinsons Dis 5:893-905
Krueger, Charlene A; Cave, Emily C; Garvan, Cynthia (2015) Fetal response to live and recorded maternal speech. Biol Res Nurs 17:112-20
Jones, Jacob D; Marsiske, Michael; Okun, Michael S et al. (2015) Latent growth-curve analysis reveals that worsening Parkinson's disease quality of life is driven by depression. Neuropsychology 29:603-9
Morishita, Takashi; Foote, Kelly D; Archer, Derek B et al. (2015) Smile without euphoria induced by deep brain stimulation: a case report. Neurocase 21:674-8
Del-Aguila, J L; Cooper-DeHoff, R M; Chapman, A B et al. (2015) Transethnic meta-analysis suggests genetic variation in the HEME pathway influences potassium response in patients treated with hydrochlorothiazide. Pharmacogenomics J 15:153-7
Chapman, Arlene B; Cotsonis, George; Parekh, Vishal et al. (2014) Night blood pressure responses to atenolol and hydrochlorothiazide in black and white patients with essential hypertension. Am J Hypertens 27:546-54

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