University in Portland Oregon the sponsors of the trial are conducting a

University in portland oregon the sponsors of the

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University, in Portland Oregon, the sponsors of the trial are conducting a portion of it themselves at the University of Pennsylvania, located in Philadelphia, Pennsylvania, finally in the US is the Vanderbilt University Medical Center, residing in Nashville, Tennessee. As far as trials outside the country go; there are two trials in Canada at Ecogene-21, in Chicoutimi, Quebec, and the Montreal Heart Institute, located in Montreal, Quebec. Furthermore, there are two trials in Italy; at the AOUP Paolo Giaccone, in Palermo, Italy, and the Policlinico Umberto I, in Roma, Italy. The final trials take place at the Erasmus MC, located in Rotterdam, Netherlands. The volunteers who will be participating in the trial will be taken from a pool that is 18 years or older, either gender, male or female, but healthy volunteers are not accepted. The final clause implies that they are only accepting people who have the disease. They estimate there will be approximately 12 people in order to fill the trial. The primary purpose of the trial is simply listed as “treatment”. This can be interpreted to mean possibly curing the patients, or at least drastically reducing the effects of the disease such as preventing the early onset cardiovascular issues. The primary outcome will be measuring the number of participants which experience “product-related adverse events”. This constitutes physical examinations, clinical laboratory parameters, and “adverse event reporting”. The time frame given for this portion of the study is as many as 52 weeks, or an entire year. The secondary outcome measures the
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  • Spring '14
  • JenniferBarton
  • Atherosclerosis, Clinical trial, Familial hypercholesterolemia, Adverse event, Gene Therapy Study

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