Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
PurGenesis Technologies Inc.
Safety/Primary Outcome Parameters: * Incidence, nature and severity of adverse events * Incidence, nature and severity of clinical laboratory test abnormalities Efficacy/Secondary Outcome Parameters: * Clinical remission defined as an endoscopy score of ≤ 1, a rectal bleeding score of 0, and an improvement or no change from baseline in the stool frequency score at the end of 2 weeks of treatment / withdrawal visit; * Clinical response rate defined as the percentage of patients with a drop of ≥3 points from the baseline overall modified Mayo score; * Patient defined response and remission rates; * Change from baseline in the overall modified Mayo score (Disease Activity Index); * Change from baseline in each of the 4 individual sub-scores of the modified Mayo score; * Change from baseline in Investigator Assessment of UC Symptom Score (total and individual symptom scores) * Change from baseline in IBDQ score (total and the 4 individual dimension scores) * Proportion of patients with treatment failure; * Change from baseline in serum lutein levels; * Change from baseline in C-reactive protein (CRP), high sensitivity CRP (hs-CRP), erythrocyte sedimentation rate (ESR), fecal calprotectin (FCP), and fecal lactoferrin (FL). * Change from baseline in exploratory biomarkers including: serum interleukin-2 (IL-2), IL-6, IL-8, interferon-gamma (IFN-gamma), tumor necrosis factor-alpha (TNF-α), transforming growth factor-beta (TGF-beta), IL-4, IL-10, IL-17, IL-23, human beta-Defensin-2 (hBD-2), malondialdehyde (MDA), lipoxin A4 (LXA4), glutathione (GSH), M30 and M65 apoptosomes in serum and biopsies, and plasma and urinary isoprostane levels.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
