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NCT ID: NCT03320876 Enrolling by invitation - Psoriatic Arthritis Clinical Trials

An Open-label, Long-term Extension Study With Filgotinib in Active Psoriatic Arthritis.

Start date: July 26, 2017
Phase: Phase 2
Study type: Interventional

This is a Phase 2, multicenter, open-label, single arm, Long Term Extension (LTE) safety, tolerability and efficacy study of filgotinib in subjects withmoderately to severely active PsA.It is estimated that approximately 105 subjects will be rolled-over after they have completed the 16 weeks of double-blind treatment in core study GLPG0634-CL-224.Subjects in the LTE study will be treated with filgotinib for a duration of 148 weeks. The LTE study is concluded with a follow-up visit approximately 4 weeks after the last intake of study treatment. Consequently, each subject will stay in the LTE study for a maximum of 152 weeks.

NCT ID: NCT03303313 Recruiting - Clinical trials for Atypical Hemolytic Uremic Syndrome

A Study of an Investigational Drug, Cemdisiran (ALN-CC5), in Patients With Atypical Hemolytic Uremic Syndrome

Start date: September 19, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of Cemdisiran in patients with aHUS.

NCT ID: NCT03267030 Recruiting - Clinical trials for Acute Lymphoblastic Leukemia

Asparaginase Encapsulated in Erythrocytes for Patients With ALL and Hypersensitivity to PEG-asparaginase

Start date: August 23, 2017
Phase: Phase 2
Study type: Interventional

Pegylated-asparaginase (PEG-ASP) is an important part of the treatment of childhood acute lymphoblastic leukaemia (ALL). Unfortunately 13% of patients develops allergy and further treatment is impossible. Furthermore, 6% of patients have developed antibodies (silent inactivation) and have no effect of the PEG-ASP treatment. Truncated asparaginase therapy is associated with inferior event-free survival outcomes, in particular relapse in central nervous system (CNS). Eryaspase is a new formulation of asparaginase encapsulated in erythrocytes. The erythrocyte membrane protects asparaginase against fast degradation and elimination processes. The encapsulation eliminates the direct somatic contact, and it is hypothesized that this provides the potential to prolong the activity of the enzyme and reduce toxicities.

NCT ID: NCT03239860 Recruiting - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an Open Label Long-term Safety Study in Patients With Multiple Sclerosis

Start date: June 6, 2017
Phase: Phase 2
Study type: Interventional

The humanised IgG4 monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human endogenous multiple sclerosis-associated retrovirus (HERV-W MSRV), which may play a critical role in multiple sclerosis. The study assesses the long-term safety of GNbAC1 in patients with RRMS and the long-term efficacy of GNbAC1 in terms of MRI outcomes, relapse rate, disability and disease progression.

NCT ID: NCT03231280 Active, not recruiting - Osteoarthritis Clinical Trials

A Trial of a Single Delivery of SB-061 in Osteoarthritis of the Knee

Start date: August 14, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This study evaluates a novel agent, SB-061, for the treatment of osteoarthritis of the knee. Half of the patients will receive the agent via intra-articular injection and half will receive a placebo injection.

NCT ID: NCT03192969 Withdrawn - Clinical trials for Giant Cell Arteritis

A Study to Evaluate Efficacy and Safety of Subcutaneous Abatacept With Steroid Treatment Compared to Steroid Treatment Alone in Adults With Giant Cell Arteritis (GCA)

Start date: July 15, 2017
Phase: Phase 3
Study type: Interventional

To investigate the safety and efficacy of abatacept with steroid treatment in comparison to steroid treatment alone in up to a 28 week taper of steroid treatment to sustain remission of Giant Cell Arteritis in adults.

NCT ID: NCT03181360 Recruiting - Ischemic Stroke Clinical Trials

Tenecteplase in Wake-up Ischaemic Stroke Trial

Start date: June 12, 2017
Phase: Phase 3
Study type: Interventional

Stroke is a leading causes of death and disability. At least 20% of strokes occur during sleep, so- called 'wake up stroke'. Thrombolysis with the clot-busting drug alteplase is effective for acute ischaemic stroke, provided that it is given within 4.5 hours of symptom onset. Patients with wake-up stroke are currently ineligible for clot-busting therapy. Previous studies indicate that many wake-up strokes occur just before awakening. In this study, patients with wake-up stroke will be randomized to thrombolysis with tenecteplase and best standard treatment or to best standard treatment without thrombolysis. Tenecteplase has several potential advantages over alteplase, including very rapid action and that it can be given as a single injection. Prior to thrombolysis, a brain scan must be done to exclude bleeding or significant brain damage as a result from the stroke. We will use a CT scan to inform this decision. CT is used as a routine examination in all stroke patients. Other studies testing clot-busting treatment in wake-up stroke are using alteplase and more complex brain scans, which are not routinely available in the emergency situation in all hospitals.

NCT ID: NCT03171311 Recruiting - Clinical trials for Ischemic Heart Disease

The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)

Start date: July 5, 2017
Phase: N/A
Study type: Interventional

The purpose is to compare median two-year clinical outcome after OCT guided vs. standard guided revascularization of patients requiring complex bifurcation stent implantation

NCT ID: NCT03165617 Recruiting - Influenza, Human Clinical Trials

Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of QIVc in Subjects ≥2 to ≤18 Years of Age

Start date: May 24, 2017
Phase: Phase 4
Study type: Interventional

The randomized, observer-blind non-influenza comparator controlled study is intended to demonstrate the efficacy, immunogenicity, safety and tolerability of Seqirus' cell-based inactivated quadrivalent vaccine (QIVc) in subjects ≥2 years to <18 years of age

NCT ID: NCT03162653 Not yet recruiting - Clinical trials for Infant, Newborn, Diseases

Effect of Allopurinol for Hypoxic-ischemic Brain Injury on Neurocognitive Outcome

Start date: June 2017
Phase: Phase 3
Study type: Interventional

Neonatal hypoxic-ischemic encephalopathy (HIE) is a major cause of death or long-term disability in infants born at term in the western world, affecting about 1-4 per 1.000 life births and consequently about 5-20.000 infants per year in Europe. Hypothermic treatment became the only established therapy to improve outcome after perinatal hypoxic-ischemic insults. Despite hypothermia and neonatal intensive care, 45-50% of affected children die or suffer from long-term neurodevelopmental impairment. Additional neuroprotective interventions, beside hypothermia, are warranted to further improve their outcome. Allopurinol is a xanthine oxidase inhibitor and reduces the production of oxygen radicals and brain damage in experimental, animal, and early human studies of ischemia and reperfusion. This project aims to evaluate the efficacy and safety of allopurinol administered immediately after birth to near-term infants with HIE in addition to hypothermic treatment.