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Anemia, Sickle Cell clinical trials

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NCT ID: NCT02567695 Completed - Sickle Cell Disease Clinical Trials

A Single-Dose Relative Bioavailability Study Of GBT440 300 mg Capsules in Healthy Subjects

Start date: September 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the relative bioavailability of a single 300 mg dose of GBT440 administered as a high strength (1 × 300 mg) capsule versus a low strength (3 × 100 mg) capsule formulation in healthy fasted subjects.

NCT ID: NCT02567682 Completed - Sickle Cell Disease Clinical Trials

Drug Interaction Study of GBT440 With Caffeine, S-warfarin, Omeprazole, and Midazolam in Healthy Subjects

Start date: September 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study to evaluate the effect of concomitant administration of GBT440 on caffeine (a CYP1A2 probe substrate), S warfarin (a CYP2C9 probe substrate), omeprazole (a CYP2C19 probe substrate), and midazolam (a CYP3A4 probe substrate) plasma concentrations.

NCT ID: NCT02565849 Completed - Sickle Cell Anemia Clinical Trials

Study of Ventilatory Mechanics in Patients With Sickle Cell Anemia

SCA
Start date: February 2013
Phase: N/A
Study type: Observational

The Sickle Cell Anemia (SCA) is a recessive genetic condition, monogenic, resulting in defects in the red cell structure. In the investigators' country, this disease affects about 3,000 children each year and is considered one of the most prevalent disorders among the group of existing hereditary diseases. The lungs are frequently affected in this disease by Acute Chest Syndrome (STA). Besides being the leading cause of death and the second leading cause of hospitalization in SCA, the STA is correlated with cognitive impairment frame these patients, resulting secondary Stroke vaso-occlusion of capillaries that supply the brain tissue. Traditional tests of pulmonary function allow assess whether the person has any commitment in the respiratory system, whether obstructive, restrictive or mixed. To run these tests it is necessary that the patient understands and performs a forced expiratory maneuver to obtain reliable results. In the particular case of SCA, performing these tests it is very difficult due to the presence of cognitive impairment of varying degrees. This results in underdiagnosis of early changes in the lung parenchyma during the therapeutic window, committing the proper monitoring and treatment offered to these patients.

NCT ID: NCT02565082 Completed - Sickle Cell Disease Clinical Trials

Evaluation of the Hemostatic Potential in Sickle Cell Disease Patients

Start date: September 2015
Phase: N/A
Study type: Interventional

Sickle cell disease is a genetic disorder caused by a point mutation on the amino acid sequence of the β chain of hemoglobin. The most expressive and most frequent complication of the disease is vaso-occlusive crisis, dominated by a painful syndrome. In addition to vaso-occlusive crises, many more chronic biological disturbances are observed in sickle cell patients.Sickle cell disease is considered nowadays as a hypercoagulable state. However, the approach used so far to the measure of clotting in sickle cell disease was segmented in the sense that the various components of the hemostatic balance were studied separately.The thrombin generation test is a functional test which explores the coagulation globally, integrating both pro players that anticoagulants actors in the system. The investigators already used this test to demonstrate that the hemostatic potential was high in a cohort of affected children compared to control children of the same age. This test will be used to characterize the hemostatic potential of adult sickle cell patients followed at the CHU Brugmann Hospital.

NCT ID: NCT02561312 Completed - Anemia, Sickle Cell Clinical Trials

Comparison of Two Methods of Transfusion for Stroke Prevention in Sickle Cell

Start date: September 2015
Phase:
Study type: Observational

Chronic blood transfusions are essential supportive care for sickle cell patients at high risk for morbidity and mortality due to stroke. These patients, however, are at risk for iron overload. In the investigator's comprehensive sickle cell center, the investigators support chronic transfusion with rapid manual partial exchange transfusions (RMPET) using a single access central line port. The investigators do not have a comprehensive adult sickle cell program but upon transition of patients the patients would be provided simple transfusion (ST) in an adult ambulatory infusion setting due to nursing acuity needed for RMPET. The investigators plan to study the institution's participants currently on chronic transfusion support and compare different transfusion modalities to better understand the effects from switching from RMPET to ST. To date, there are no such comparisons within and between sickle cell patients in the literature.

NCT ID: NCT02560935 Completed - Stroke Clinical Trials

Primary Prevention of Stroke in Children With SCD in Sub-Saharan Africa II

SPRING
Start date: July 19, 2016
Phase: Phase 3
Study type: Interventional

The overall goal of this proposal is to conduct a partial double-blind randomized Phase III clinical trial for primary stroke prevention in children with sickle cell anemia (SCA) in sub-Saharan Africa.

NCT ID: NCT02556099 Active, not recruiting - Sickle Cell Anemia Clinical Trials

EXTEND EXpanding Treatment for Existing Neurological Disease

Start date: August 2014
Phase: Phase 2
Study type: Interventional

The primary goal of the Phase II EXTEND trial is to investigate the effects of open-label hydroxyurea treatment, escalated to maximum tolerated dose, for children with Sickle Cell Anemia and either conditional (170 - 199 cm/sec) or abnormal (≥200 cm/sec) Transcranial Doppler velocities. The primary endpoint will be measured after 18 months of hydroxyurea but treatment will continue until a common study termination date.

NCT ID: NCT02539771 Completed - Sickle Cell Disease Clinical Trials

Sleep Study in Adult Patients With Major Sickle Cell Disease With Paroxysmal Nocturnal Events

DREPASOM
Start date: September 17, 2014
Phase: N/A
Study type: Interventional

Hypothesis is that the occurrence of nocturnal Vaso-Occlusive Crisis (VOC) and priapism in adults might be related to episodes of nocturnal desaturation secondary to a sleep apnea syndrome. Investigator hypothesize that chronic biological consequences of Obstructive Sleep Apnea (hypercoagulability, endothelial dysfunction ...) favour VOC and acute manifestations (nocturnal desaturation) favour nocturnal VOC. The confirmation of this hypothesis will lead investigator to propose a systematic screening of obstructive sleep apnea (OSA) in patients with nocturnal VOC. Moreover, systematic treatment of OSA in sickle cell patients could help significantly reduce the number and severity of nocturnal VOC.

NCT ID: NCT02536170 Completed - Sickle Cell Disease Clinical Trials

Arginine Therapy for Sickle Cell Disease Pain

Start date: February 2016
Phase: Phase 2
Study type: Interventional

The aim of this study is to determine whether giving extra arginine, a simple amino acid, to patients with sickle cell disease seeking treatment for a pain crisis (vaso-occlusive painful events (VOE) will decrease pain scores, decrease the need for pain medications or decrease length of hospital stay or emergency department visit. Funding Source - FDA OOPD.

NCT ID: NCT02530242 Completed - Sickle Cell Anemia Clinical Trials

Carbon Monoxide Measurement to Screen for Sickle Cell Disease

SCDCO
Start date: July 2015
Phase: N/A
Study type: Interventional

Modify the design of the CoSense device (Model C20112, currently cleared by the FDA for ETCO (end-tidal carbon monoxide) monitoring to improve accuracy and consistency under temperature conditions encountered in countries with high prevalence of SCD (Sickle Cell Disease).