8 results
The objective of this study is to evaluate efficacy and the safety of GelrinC® implant microfracture in the treatment of patients with symptomatic articular cartilage defect(s) of the femoral condyle.
Please refer to protocol, section 1.2 "Rationale"
The primary objective of the study is:* To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by evinacumab 15 mg/kg intravenously (IV) in comparison to placebo after 24 weeks in patients with homozygous familial…
To demonstrate the superior clinical efficacy of GelrinC on pain and function for the treatment of symptomatic focal articular cartilage defects of the femoral condyle in comparison to microfracture historical control at 24 months post-surgery.
PrimaryThe primary objective for Part A of the study is to assess the pharmacokinetics (PK) of evinacumab in pediatric patients with homozygous familial hypercholesterolemia (HoFH).The primary objective for Part B of the study is to demonstrate a…
The primary objective of the study is to determine the proportion of patients with elevated TGs, without Familial ChylomicronemiaSyndrome (FCS) due to loss of function (LoF) mutations in lipoprotein lipase (LPL), and a history of…
To evaluate the efficacy of each combination arm, as measured by confirmed objective response rate (ORR)
The primary objectives of the study are- To evaluate the long-term safety and tolerability of evinacumab 15 mg/kg intravenous (IV) administered every 4 weeks (Q4W) in patients with homozygous familial hypercholesterolemia (HoFH).- To evaluate the…