11 results
To determine whether fibrinogen concentrate infusion reduces perioperative blood loss and transfusion in patient experiencing clinically relevant microvascular bleeding during elective complex cardiac surgery and to determine whether its use is safe…
Primary ObjectiveTo evaluate the clinical efficacy of apremilast (30 mg twice daily [BID] and 40 mg BID), compared with placebo, in subjects with active UC.Secondary Objective To evaluate the safety and tolerability of apremilast (30 mg BID and 40…
Estimate the efficacy of apremilast compared with placebo in the treatment of Juvenile Psoriatic Arthritis (JPsA) in pediatric subjects 5 to less than 18 years of age.Refer to section 3 of the protocol for more information.
Primary Objective• To evaluate the efficacy of apremilast 30 mg BID * NSAIDs and/or csDMARDs vs. Placebo * NSAIDs and/or csDMARDs in subjects with early oligoarticular PsA, assessed by modified MDA (MDA-Joints).Secondary Objectives · To evaluate the…
Primary Objective- To evaluate the clinical efficacy and safety of oral apremilast (APR) 30 mg twice a day (BID) compared with placebo, in subjects with moderate to severe plaque psoriasis at Week 16.Secondary Objectives- To evaluate the clinical…
The purpose of this study is to answer the following question: Leads a primary coagulation corrected with a single dose of fibrinogen concentrate after ascending aorta-arc reconstruction to a decrease in the number of allogenic blood transfusions,…
Primary objectives: To evaluate the expression of inflammatory cytokines in HS lesional skin at week four (t=4) and week sixteen (t=16): - of subjects receiving apremilast compared to subjects receiving placebo;- within both groups relative to…
Primary-Assess the efficacy of apitegromab compared with placebo using the HFMSE in patients 2 through 12 years oldKey secondary-Assess the efficacy of apitegromab compared with placebo based on the number of patients with clinical improvement in…
-Evaluate the long-term safety and tolerability of apitegromab in patients with Type 2 and Type 3 SMA-Evaluate the long-term efficacy of apitegromab by assessing changes in motor function outcome measures at prespecified time points-Further evaluate…
The main objective of study 20190530 is to estimate the efficacy of Apremilast compared to placebo in the treatment of oral ulcers in pediatric subjects from 2 to < 18 years of age with oral ulcers associated with BD through week 12. See…
Primary ObjectiveThe primary objective of the study is to evaluate the clinical efficacy of apremilastcompared with placebo in children and adolescents (ages 6 through 17 years) withmoderate to severe plaque psoriasis.Secondary Objectives- * To…