8 results
To provide, or continue to provide, UT-15C SR for eligible subjects who participated in protocols TDE-PH-301 or TDE-PH-302 or TDE-PH-308 or additional UC-15C SR clinical protocols.To assess the long-term safety of UT-15C SR in these subjects through…
Primary: To assess the effect of UT-15C sustained release (SR) on exercise capacity compared to placebo (as measured by the change in 6-Minute Walk distance from Baseline to Week 12) in subjects with PAH who are not currently receiving ERA, PDE-5…
The primary aim of the phase I part of this trial is to establish the safety of a split dose regimen of Re-188-HEDP . The primary aim of the phase II part of this trial is to obtain insight in the efficacy of a split dose regimen of Re-188-HEDP , as…
Phase IThe primary aim of the phase I part of this study is to establish the safety profile and to determine the maximum tolerated dose of Re-188-HEDP combined with Capecitabine.Phase IIThe primary aim of the phase II part of this study is to obtain…
The primary aim of the phase I part of this study is to establish the safety profile and to determine the maximum tolerated dose of capecitabine combined with Re-188-HEDP.The primary aim of the phase II part of this study is to obtain insight in the…
The objective of this trial is to compare standard treatment with radium-223-chloride (proven surivval benefit) with treatment with rhenium-188-HEDP, which is nowadays only used for pain palliation. This trial includes patients with metastatic…
Primary objectives:To establish a safe and effective dosing schedule for repeated administration of Rhenium-188 HEDP combined with Cabazitaxel in order to proceed with a Randomised Phase 2 trial designed to determine the clinical value of Rhenium-…
Primary: To assess the effect of UT-15C sustained release (SR) on exercise capacity compared to placebo (as measured by the change in 6-Minute Walk distance from Baseline to Week 16) in subjects with PAH.Secondary: To assess the effect of UT-15C SR…