Marseille cedex, France Clinical Trials

Randomization will take place once the consented patient has completed all the necessary baseline procedures and is deemed eligible for study entry. Treatment assignment will be done centrally using a dynamic allocation method (biased coin) via an interactive voice/web response system (IXRS) stratified by: Geographical region (Region 1: Asian [Japan]; ...

Parts A and B will consist of 3 periods: Screening, Treatment and Follow-up. Screening Period The Screening Period starts 28 days ( 3 days) prior to first dose of CC-90011. The informed consent document (ICD) must be signed and dated by the subject and the administering staff prior to the ...

The pathophysiology of Central Retinal Vein Occlusion (CRVO) is incompletely understood, but a significant slow-down in blood flow, caused by various predisposing factors, results in the release of VEGF, leading to the breakdown of the blood-retinal-barrier and finally to macular edema. The level of VEGF has been also correlated with ...

Approximately 405 patients will be randomized using an Interactive Voice Response System /Interactive web system (IVR/IWR system) in a 1:2 ratio to the treatments as specified below: Arm A: Placebo + bevacizumab & platinum-based chemotherapy. The placebo arm will include one of 3 following regimens up to investigator choice (chosen ...

This is a multicenter, randomized, open-label, active-controlled Phase 3 study of the efficacy and safety of vadadustat versus darbepoetin alfa for the maintenance treatment of anemia in subjects with DD-CKD

This is a single-arm, multi-site, single-dose, Phase 3 study in approximately 23 subjects 50 years of age with transfusion-dependent -thalassemia (TDT), also known as -thalassemia major, who do not have a 0 mutation at both alleles of the hemoglobin (HBB) gene. The study will evaluate the efficacy and safety of ...

The EMINENT study is a prospective, multi-center study confirming the superior effectiveness of the ELUVIA stent versus Self-Expanding Bare Nitinol Stents in the treatment of lesions 30-210 mm long located in the femoropopliteal arteries in subjects with symptoms classified as Rutherford categories 2-4. The study is a 2:1 randomized (ELUVIA ...

This is a single-arm, open-label, extended treatment, safety study in patients treated with talazoparib in qualifying studies.

The purpose of this study is to determine the safety and tolerability of weekly intravenous (IV) administration of XmAb13676 and to determine the maximally tolerated dose (MTD) after the first dose, and then to determine the MTD after second and subsequent infusions.

Despite decades of treatment and great diversity of instrumentation, the objective of sagittal spinal realignment in adult spinal deformity is achieved in only 38% of patients which reflects an inadequacy of the approach currently used. Patient specific rods were created by Medicrea to address this gap and support surgeons in ...