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NCT ID: NCT03193203 Completed - Healthy Clinical Trials

Pharmacokinetics, Safety, and Tolerability Study of the Autoinjector and Pre-filled Syringe of SB4 in Healthy Male Subjects

Start date: March 24, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of the autoinjector and pre-filled syringe of SB4 in healthy male subjects.

NCT ID: NCT03191799 Completed - Hemophilia A Clinical Trials

A Study to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors

STASEY
Start date: September 5, 2017
Phase: Phase 3
Study type: Interventional

This is a phase IIIb, single arm, open-label, multi-center study to evaluate the safety and tolerability of emicizumab in participants with congenital hemophilia A who have documented inhibitors against Factor VIII (FVIII) at enrollment. Approximately 200 participants, aged 12 or older, will be enrolled in this study and are expected to be enrolled at approximately 85 sites globally. Participants will receive an initial weekly dose of prophylactic emicizumab subcutaneously for 4 weeks, followed by a weekly maintenance dose subcutaneously for the remainder of the 2-year treatment period.

NCT ID: NCT03190694 Completed - Clinical trials for Chronic Kidney Diseases

Effects of Dapagliflozin in Non-diabetic Patients With Proteinuria

DIAMOND
Start date: November 12, 2017
Phase: Phase 2
Study type: Interventional

This study tests the hypothesis that dapagliflozin lowers proteinuria in patients with non-diabetic chronic kidney disease.

NCT ID: NCT03189303 Completed - Clinical trials for Osteoarthritis; Rheumatoid Arthritis; Post Traumatic Arthritis

Cup Position in THA With Standard Instruments

Start date: September 7, 2017
Phase:
Study type: Observational

Prospective, global, multicenter study to assess cup position in THA. After written informed consent has been obtained, study evaluations will be collected from the pre-op clinic visit, the operative visit (including discharge), and 6 and 12 weeks postoperatively.

NCT ID: NCT03188666 Completed - Clinical trials for Fibrodysplasia Ossificans Progressiva

A Study to Examine the Safety, Tolerability and Effects on Abnormal Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans Progressiva

LUMINA-1
Start date: February 26, 2018
Phase: Phase 2
Study type: Interventional

This is a three period study design consisting of a 6-month, randomized, double-blind placebo-controlled treatment (period 1) followed by a 6-month, open-label treatment (period 2) and a follow-up treatment period (period 3). Primary safety objective of the study is to assess the safety and tolerability of REGN2477 in male and female patients with fibrodysplasia ossificans progressiva (FOP). Primary efficacy objective of the study is to assess the effect of REGN2477 versus placebo on the change from baseline in heterotopic ossification (HO) in patients with FOP, as determined by 18-NaF uptake in HO lesions by positron emission tomography (PET) and in total volume of HO lesions by computed tomography (CT). Key Secondary objectives are: - To compare the effect of REGN2477 versus placebo on pain due to FOP, as measured by the area under the curve (AUC) for pain based on daily pain numeric rating scale (NRS) scores - To assess the effect of REGN2477 versus placebo on the change from baseline in HO, as determined by the number of new HO lesions identified by 18F-NaF PET or by CT - To assess the effect of REGN2477 versus placebo on the change from baseline in 18F-NaF standardized uptake value maximum (SUVmax) of individual active HO site(s) by PET - To assess the effect of REGN2477, between week 28 and week 56, on the number, activity, and volume of HO lesions identified by 18F-NaF PET or by CT in patients who switch from placebo to REGN2477 at week 28 versus the same patients between baseline and week 28 - To assess the effect of REGN2477 versus placebo on the change from baseline in biochemical markers of bone formation - To characterize the concentrations of total activin A at baseline and over time following the first dose of study drug - To characterize the concentration-time profile (pharmacokinetics [PK]) of REGN2477 in patients with FOP - To assess the immunogenicity of REGN2477

NCT ID: NCT03186989 Completed - Clinical trials for Mild Alzheimer's Disease

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS-MAPTRx in Patients With Mild Alzheimer's Disease

Start date: October 12, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IONIS-MAPTRx in patients with Mild Alzheimer's Disease

NCT ID: NCT03184623 Completed - Muscle Loss Clinical Trials

Muscle Mass and Body Composition

Start date: June 9, 2017
Phase: N/A
Study type: Observational

ICUacquired weakness is a common complication of critical illness, particularly in patients receiving mechanical ventilation and/or suffering from conditions leading to the systemic inflammatory response syndrome.

NCT ID: NCT03184194 Completed - Myeloma Clinical Trials

Nivolumab Combined With Daratumumab With or Without Low-dose Cyclophosphamide

Start date: February 21, 2018
Phase: Phase 2
Study type: Interventional

Evaluation of the effect of nivolumab and daratumumab with or without low-dose cyclophosphamide in patients with relapsed/refractory multiple myeloma.

NCT ID: NCT03183414 Completed - Clinical trials for Right Ventricular Dysfunction

Right Ventricular Dysfunction in Cardiac Surgery Patients

Start date: September 6, 2017
Phase:
Study type: Observational

To establish the correlation between echocardiographic parameters of the RV, measured with TEE and the right ventricular ejection fraction (thermodilution). To identify a time in the perioperative process when RV dysfunction occurs.

NCT ID: NCT03181217 Completed - Healthy Clinical Trials

Functional Magnetic Resonance Imaging of Human Hypothalamic Responses to Oral Temperature and Glucose Sensing

COLD
Start date: January 28, 2013
Phase: N/A
Study type: Interventional

The study will consist of four occasions with one week between the occasions. fMRI will be performed to monitor hypothalamic activity before and after an ingestion of 1 of the following 4 stimuli (300 ml of each): water at room temperature, water at 0 degrees Celsius, glucose solution at room temperature, glucose solution at 0 degrees Celsius. The last two stimuli both contain 75 gram glucose. The order of conditions will be randomly assigned to the subjects. Functional connectivity of the hypothalamic regions will be assessed by analysing the resting state fMRI.