7 results
Cohort 1:A data monitoring committee (DMC) will evaluate all available safety data from the study. The first 2 meetings for safety surveillance will occur after 50 and 100 subjects complete or discontinue from the Blinded Induction Phase from Cohort…
The primary objectives of this study are as follows:* To assess the safety and tolerability of escalating single and multiple doses of GS-5745 in subjects with moderate to severe ulcerativecolitis (UC) as assessed by adverse events (AEs), and…
Objectives. The goals of the current protocol is therefore the natural follow-up of the objectives achieved with the previous grants and, in particular, of projects designed to discern new models for the successful conduct of clinical trials in…
To decrease the cumulative incidence of (hematological) relapse
1. Primary Objectives• To evaluate the safety and tolerability of VX 440 monotherapy and VX 440 in dual and triple combination with VX-661 and IVA• To evaluate the efficacy of VX 440 monotherapy and VX 440 in dual and triple combination with VX 661…
Objectives: - to increase the proportion of patients with non-severe GVHD within 180 days post-allo-SCT - to reduce the progression rate - to improve the progression free survival- to asses the impact on the quality of life using a time restricted…
The device, the cardiac arrhythmia software, is intended to record, store and analyze the heart rate data collected by a PPG sensor to provide the user with notifications of events that indicate an irregular heart rhythm. The information is not…