2 results
Approved WMOCompleted
The primary objectives of the trial are to:- Evaluate the efficacy of the PCL-based bulking agent treatment as determined by the Stamey Grading System (SGS). The SGS will be determined at baseline, 3, 6, 12, 18, and 24 months follow-up. - Evaluate…
Approved WMOCompleted
Primary:* To obtain data on long term safety and tolerability on vedolizumab SC in subjects with Ulcerative Colitis (UC) or Crohn's Disease (CD).Secondary:* To obtain data on adverse events of special interest (AESIs; serious infections…