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An Open Label,Safety Extension of Eurand Study PR-011

2014-07-23 21:08:57 | BioPortfolio

Summary

A Study to determine long term safety of EUR-1008 3,000 lipase units capsules (the "EUR-1008"), a Pancreatic Enzyme Product ("PEP"), in infants with CF who need to take PEP medications to help break down the food that they eat.

Description

Multi-center, Open-Label, Safety Extension of Eurand Study PR-011 in pediatric subjects with EPI associated with CF. The study will be carried out in infants greater than 1 month of age.

The study is comprised of 5 visits: an Enrollment Visit, Treatment Visit 1(3 months), Treatment Visit 2(6 months),Treatment Visit 3(9 months), and Treatment Visit 4(12 months). Once determined eligible for participation, subjects will be enrolled into the study.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Cystic Fibrosis

Intervention

EUR-1008 3,000

Location

University of California, San Francisco Pediatrics
San Francisco
California
United States
94107

Status

Not yet recruiting

Source

Eurand S.p.A.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:57-0400

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Medical and Biotech [MESH] Definitions

An autosomal recessive genetic disease of the EXOCRINE GLANDS. It is caused by mutations in the gene encoding the CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR expressed in several organs including the LUNG, the PANCREAS, the BILIARY SYSTEM, and the SWEAT GLANDS. Cystic fibrosis is characterized by epithelial secretory dysfunction associated with ductal obstruction resulting in AIRWAY OBSTRUCTION; chronic RESPIRATORY INFECTIONS; PANCREATIC INSUFFICIENCY; maldigestion; salt depletion; and HEAT PROSTRATION.

A chloride channel that regulates secretion in many exocrine tissues. Abnormalities in the CFTR gene have been shown to cause cystic fibrosis. (Hum Genet 1994;93(4):364-8)

A strain of mice widely studied as a model for cystic fibrosis. These mice are generated from embryonic stem cells in which the CFTR (cystic fibrosis transmembrane conductance regulator) gene is inactivated by gene targeting. As a result, all mice have one copy of this altered gene in all their tissues. Mice homozygous for the disrupted gene exhibit many features common to young cystic fibrosis patients, including failure to thrive, meconium ileus, and alteration of mucous and serous glands.

A species of STENOTROPHOMONAS, formerly called Xanthomonas maltophilia, which reduces nitrate. It is a cause of hospital-acquired ocular and lung infections, especially in those patients with cystic fibrosis and those who are immunosuppressed.

A rehabilitation therapy for removal of copious mucus secretion from the lung of patients with diseases such as CHRONIC BRONCHITIS; BRONCHIECTASIS; PULMONARY ABSCESS; or CYSTIC FIBROSIS. The patient's head is placed in a downward incline (so the TRACHEA is inferior to the affected area) for 15- to 20-minute sessions.

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