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. Altus Biologics has developed a pancreatic enzyme replacement product, TheraCLEC -Total, which consists of lipase, protease and amylase, intended to aid in the digestion of fats, proteins and carbohydrates in pancreatic insufficient subjects. This is a double blind, multicenter study of TheraCLEC -Total in pancreatic-insufficient subjects with cystic fibrosis (CF). The study plans to enroll 140 subjects. The study is separated into four periods; screening period, baseline period, treatment period, and follow up. The baseline and treatment periods require inpatient care at a clinical research center (CRC). Pancreatic insufficiency (PI) is present in greater than 85% of all patients with CF by the age of 8 to 9 years.1 Both the abnormal amounts and viscosity of mucus in CF patients impede the secretion of sufficient pancreatic enzymes. Uncorrected maldigestion and malabsorption lead to malnutrition, failure to gain or maintain weight, decreased growth, and worsening of chronic suppurative lung disease.2,3,4 CF patients with PI typically absorb less than 60% of dietary fat.4,5 Usual treatment of PI includes coated or uncoated enzyme supplementation containing porcine pancreatic enzyme concentrate, which includes lipases, proteases and amylases. Currently, all such enzyme replacement products are given orally with meals and snacks at a dose level titrated to clinical symptoms, and in some instances fat absorption measures. As these products pass through the low pH environment of the stomach, enzyme activity rapidly diminishes. Therefore large quantities of enzyme concentrate have been required to ensure that active enzyme is present in the proximal intestine to treat PI.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000750-34
Application #
7379123
Study Section
Special Emphasis Panel (ZRR1-CR-8 (01))
Project Start
2005-12-01
Project End
2006-11-30
Budget Start
2005-12-01
Budget End
2006-11-30
Support Year
34
Fiscal Year
2006
Total Cost
$20,201
Indirect Cost
Name
Indiana University-Purdue University at Indianapolis
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
603007902
City
Indianapolis
State
IN
Country
United States
Zip Code
46202
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
Robinson-Cohen, Cassianne; Bartz, Traci M; Lai, Dongbing et al. (2018) Genetic Variants Associated with Circulating Fibroblast Growth Factor 23. J Am Soc Nephrol 29:2583-2592
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
Gupta, Samir K; Yeh, Eunice; Kitch, Douglas W et al. (2017) Bone mineral density reductions after tenofovir disoproxil fumarate initiation and changes in phosphaturia: a secondary analysis of ACTG A5224s. J Antimicrob Chemother 72:2042-2048
Robarge, Jason D; Desta, Zereunesay; Nguyen, Anne T et al. (2017) Effects of exemestane and letrozole therapy on plasma concentrations of estrogens in a randomized trial of postmenopausal women with breast cancer. Breast Cancer Res Treat 161:453-461
Hertz, Daniel L; Speth, Kelly A; Kidwell, Kelley M et al. (2017) Variable aromatase inhibitor plasma concentrations do not correlate with circulating estrogen concentrations in post-menopausal breast cancer patients. Breast Cancer Res Treat 165:659-668
Patel, Yash R; Kirkman, M Sue; Considine, Robert V et al. (2017) Retinopathy predicts progression of fasting plasma glucose: An Early Diabetes Intervention Program (EDIP) analysis. J Diabetes Complications 31:605-610
Robarge, Jason D; Metzger, Ingrid F; Lu, Jessica et al. (2017) Population Pharmacokinetic Modeling To Estimate the Contributions of Genetic and Nongenetic Factors to Efavirenz Disposition. Antimicrob Agents Chemother 61:
Hertz, D L; Kidwell, K M; Seewald, N J et al. (2017) Polymorphisms in drug-metabolizing enzymes and steady-state exemestane concentration in postmenopausal patients with breast cancer. Pharmacogenomics J 17:521-527
Kadakia, Kunal C; Kidwell, Kelley M; Seewald, Nicholas J et al. (2017) Prospective assessment of patient-reported outcomes and estradiol and drug concentrations in patients experiencing toxicity from adjuvant aromatase inhibitors. Breast Cancer Res Treat 164:411-419

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