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NCT ID: NCT03588026 Recruiting - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria (PNH)

Treating Paroxysmal Nocturnal Haemoglobinuria Patients With rVA576

CAPSTONE
Start date: June 20, 2018
Phase: Phase 3
Study type: Interventional

rVA576 for patients with Paroxysmal Nocturnal Hemoglobinuria (PNH).

NCT ID: NCT03585933 Not yet recruiting - Clinical trials for Aortic Stenosis, Calcific

Prognostic Value of Myocardial Fibrosis in Severe Aortic Valve Stenosis

FIB-AS
Start date: September 2018
Phase:
Study type: Observational

Degenerative aortic valve stenosis (AS) is the most common valve heart disease in the developed Western countries. The hemodynamic progression of AS occurs over time and leads to LV hypertrophy (LVH) as a compensation mechanism of the heart. Morphological changes such as increasing muscle fibre thickness, collagen volume, and interstitial fibrosis occur in AS patients. These changes result in left ventricular (LV) diastolic and systolic dysfunction and, consequently, to with AS related symptoms. When symptoms associated with AS appear, patients' prognosis is poor if surgical aortic valve replacement (SAVR) or a trans-catheter aortic valve implantation (TAVI) is not performed. Primary hypothesis of the research: fibrotic changes in the myocardium are related to immediate (in hospital) or long-term complications (MACE and all-cause mortality) in patients with severe AS. The goal of the study is to determine the prognostic implications of focal as well as diffuse myocardial fibrosis in patients with severe aortic valve stenosis.

NCT ID: NCT03581656 Recruiting - Clinical trials for Mitral Regurgitation

ChordArt System for Mitral Regurgitation

CHAGALL
Start date: March 21, 2018
Phase: N/A
Study type: Interventional

The ChordArt System is a novel catheter based technology for mitral chordal replacement that enables controlled implantation of artificial mitral chords to treat mitral regurgitation with a minimally invasive approach. The implant is designed to allow transfemoral antegrade implantation.

NCT ID: NCT03552393 Recruiting - Anemia Clinical Trials

Ascertain the Optimal Starting Dose of Mircera Given Subcutaneously for Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis.

Start date: May 8, 2018
Phase: Phase 2
Study type: Interventional

Ascertain the starting dose of Mircera given subcutaneously for the maintenance treatment of anemia in pediatric participants with chronic kidney disease (CKD) on dialysis or not yet on dialysis when switching from stable subcutaneous (SC) maintenance treatment with epoetin alfa, epoetin beta, or darbepoetin alfa.

NCT ID: NCT03548415 Recruiting - Acromegaly Clinical Trials

Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in up to 42 Adult Patients With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands

Start date: July 2018
Phase: Phase 2
Study type: Interventional

The purpose is to assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in up to 42 Patients with Acromegaly

NCT ID: NCT03528551 Enrolling by invitation - Clinical trials for Congenital Bleeding Disorder

A Research Study Looking at How a Factor VIII Medicine Called Turoctocog Alfa Pegol (N8-GP) Works in People With Haemophilia A

pathfinder8
Start date: April 30, 2018
Phase: Phase 3
Study type: Interventional

This study will look at how a known study medicine N8-GP works in previously N8-GP treated people with haemophilia A. The aim is to look at how N8-GP works during regular use. Participants will get N8-GP. N8-GP has been tested in more than 200 people with haemophilia A for several years. Participants will get an injection of N8-GP into a blood vessel, one, two or three times weekly. Participants will get more doses if they bleed or if they will need a surgery. The study will last for about 2 years. Participants will have at least 9 visits with the study doctor. If participants agree to be in this study, they will get their first injection (in this study) at the first visit. Participants will also get an injection at visit 3, 5 and 7. Participants will be trained to give all other injections themselves. Participants must not use any clotting factors other than N8-GP or any anticoagulants (blood thinners) during the study.

NCT ID: NCT03517722 Recruiting - Clinical trials for Lupus Erythematosus, Systemic

A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus

Start date: April 16, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard of care treatments.

NCT ID: NCT03496298 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

Effect of Efpeglenatide on Cardiovascular Outcomes

AMPLITUDE-O
Start date: April 27, 2018
Phase: Phase 3
Study type: Interventional

Primary Objective: -To demonstrate that, efpeglenatide doses 1 and 2 is noninferior to placebo on 3-point major adverse cardiac event (MACE) in Type 2 diabetes mellitus (T2DM) patients at high cardiovascular (CV) risk. Secondary Objectives: - To demonstrate that efpeglenatide doses 1 and 2 is superior to placebo in T2DM patients with high CV risk on the following parameters: - 3-point MACE. - Expanded CV outcome. - Composite outcome of new or worsening nephropathy. - To assess the safety and tolerability of efpeglenatide doses 1 and 2, both added to standard of care in T2DM patients at high CV risk.

NCT ID: NCT03491163 Recruiting - Clinical trials for Heart; Surgery, Heart, Functional Disturbance as Result

Evaluation of Damaging Factors to Endothelial Glycocalyx During Heart Surgery Pilot Study

Start date: March 29, 2018
Phase:
Study type: Observational

Evaluation of endothelial glycocalyx damage in on-pump conventional coronary artery bypass surgery using a syndecan-1 (CD138) blood test. The study will be carried out in two stages. Pilot study for testing and correcting research methodology and the main study.

NCT ID: NCT03466411 Recruiting - Crohn's Disease Clinical Trials

A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

GALAXI
Start date: April 13, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this program is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.