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Pulmonary Hypertension in Sickle Cell Anemia

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181. Evaluation of Dose Response Relationship, Safety and Efficacy of GSK1278863 in Hemodialysis-dependent Subjects With Chronic Kidney Disease Associated Anemia

-dialysis vitals (Week -4, Day 1) of diastolic blood pressure (DBP) >100 millimeters of mercury (mmHg) or systolic blood pressure (SBP) >170 mmHg. Thrombotic disease: History of thrombotic disease (e.g., venous thrombosis such as deep vein thrombosis or pulmonary embolism, or arterial thrombosis such as new onset or worsening limb ischemia requiring intervention), except vascular access thrombosis, within the 8 weeks prior to Week -4 Screening through Day 1 (randomization). Other disease-related (...) criteria Ophthalmology disease: Meeting any ophthalmologic-related exclusion criteria determined at the Screening ophthalmology exam. Inflammatory disease: Active chronic inflammatory disease that could impact erythropoiesis (e.g., scleroderma, systemic lupus erythematosis, rheumatoid arthritis, celiac disease) diagnosed prior to Week -4 Screening through Day 1 (randomization). Hematological disease: Any hematological disease including those affecting platelets, white or red blood cells (e.g. sickle

2013 Clinical Trials

182. Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934

infarction, stroke, transient ischemic attack, deep vein thrombosis, pulmonary embolism) within the last 6 months from the initial screening visit Sustained, poorly controlled arterial hypertension or hypotension at screening, defined as a mean BP ≥ 180/110 mmHg or systolic BP < 95 mmHg, respectively Severe rhythm or conduction disorder (e.g., HR < 50 or > 110 bpm, atrial flutter, prolonged QT >500 msec, second or third degree atrioventricular [AV]block if not treated with a pacemaker) New York Heart (...) hemoglobinopathies (including, but not limited to, sickle cell disease, beta thalassemia, and thalassemia major) which may be the primary cause of anemia Chronic lymphoproliferative diseases Any allograft (including renal allograft) in place and on immunosuppressive therapy, or a scheduled kidney transplant within the next 16 weeks (being on a waiting list does not exclude the subject) Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac

2013 Clinical Trials

183. FG-4592 (ASP1517) in the Treatment of Anemia in Chronic Kidney Disease Patients Not Requiring Dialysis

, seizure, or a thrombotic/thromboembolic event (e.g., pulmonary embolism) within 12 weeks prior to randomization. Uncontrolled hypertension or two or more blood pressure (BP) values of systolic BP (SBP) greater than or equal to 160 mmHg or diastolic BP (DBP) greater than or equal to 95 mmHg confirmed by repeat measurement within 2 weeks prior to randomization. Subject has a diagnosis or suspicion (e.g., complex kidney cyst of Bosniak Category 2F or higher) of renal cell carcinoma on renal ultrasound (...) Sponsor: Astellas Pharma Europe B.V. Collaborator: FibroGen Information provided by (Responsible Party): Astellas Pharma Inc ( Astellas Pharma Europe B.V. ) Study Details Study Description Go to Brief Summary: This study is conducted to treat anemia in patients with chronic kidney disease. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin is important for the transport of oxygen in your blood. The purpose of the study is to see if Roxadustat is both effective and safe

2013 Clinical Trials

184. 4 Week Switch Study in Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney Disease

haematological disease including those affecting platelets, the coagulation disorders (e.g., Protein C or S deficiency) or red blood cells (e.g. sickle cell anemia, myelodysplastic syndromes, haematological malignancy, myeloma, haemolytic anemia) or any other cause of anemia other than renal disease. Liver disease: Current liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) or evidence at Screening of abnormal liver function tests (...) months. Pulmonary hypertension: Known pulmonary hypertension and those at higher risk (than normally associated with CKD) for pre-existing elevation in pulmonary pressure (e.g., significant heart failure or lung disease requiring supplemental oxygen, or those with connective tissue diseases). Inflammatory disease: Chronic inflammatory disease that could impact erythropoiesis (e.g., scleroderma, systemic lupus erythematosis, rheumatoid arthritis, celiac disease). Haematological disease: Any

2012 Clinical Trials

185. 4 Week Correction Study in Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Undergoing Dialysis

). Hematological disease: Any hematological disease including those affecting platelets, the coagulation disorders (e.g., Protein C or S deficiency) or red blood cells (e.g. sickle cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma, hemolytic anemia) or any other cause of anemia other than renal disease. Liver disease: Current liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) or evidence at Screening of abnormal (...) related condition) within the prior 6 months. Pulmonary hypertension: Known pulmonary hypertension and those at higher risk (than normally associated with CKD) for pre-existing elevation in pulmonary pressure (e.g., significant heart failure or lung disease requiring supplemental oxygen, or those with connective tissue diseases). Inflammatory disease: Chronic inflammatory disease that could impact erythropoiesis (e.g., scleroderma, systemic lupus erythematosis, rheumatoid arthritis, celiac disease

2012 Clinical Trials

186. A Reduced Toxicity Allogeneic Unrelated Donor Stem Cell Transplantation (SCT) for Severe Sickle Cell Disease

a novel reduced toxicity regimen for stem cell transplant with unrelated donors. Analysis will be geared to confirm if the study regimen, followed by an appropriately HLA-matched unrelated donor (MUD)or unrelated cord blood HSCT, can lead to durable donor engraftment with reasonable toxicity, inhibiting sickle erythropoiesis and limiting disease related organ toxicity in patients who are at high risk for morbidity and mortality associated with sickle cell disease (SCD). Study Design Go to Layout table (...) as 3 or more severe pain events per year in the 2 years prior to enrollment despite adequate supportive care measures and hydroxyurea trial (i.e. Hydroxyurea non-responders). Pain may occur in typical sites associated with vaso-occlusive painful events and cannot be explained by causes other than vaso-occlusion mediated by sickle cell disease. Recurrent priapism. Osteo-necrosis of multiple joints Evidence of Pulmonary Hypertension as evidenced by Tricuspid Regurgitation jet velocity (TRV) > 2.5 m/s

2011 Clinical Trials

187. Nitric Oxide and Sickle Cell Pain

(such as meats like ham and bacon and vegetables like beets and spinach). At each of the four study visit, participants will bring the pain diary, provide blood samples, and have breath nitric oxide tests. Condition or disease Sickle Cell Disease Pain Detailed Description: Sickle cell disease is a systemic disorder whose proximate cause is a mutation in the beta-globin chain of hemoglobin. Although it is characterized by differing degrees and patterns of clinical manifestations, its major features include (...) disease often causes crises, with episodes of pain. Many people with sickle cell disease also have pain between crises. Inflammation is an important part of sickle cell pain. It may be related to levels of nitric oxide. Nitric oxide is a gas in the body that helps relax blood vessels and may be related to the pain from sickle cell disease. Researchers want to study the relationship between blood levels of nitric oxide and pain in people with sickle cell disease. Researchers also want to study how

2011 Clinical Trials

188. Hydroxyurea to Prevent Brain Injury in Sickle Cell Disease

or disease Intervention/treatment Phase Sickle Cell Disease Stroke Drug: Hydroxyurea Drug: Placebo Phase 2 Detailed Description: Stroke, silent cerebral infarct (SCI), and cognitive impairment are frequent and highly morbid complications of sickle cell disease (SCD) in children. Current approaches to the prevention and treatment of neurological complications in SCD include screening by transcranial Doppler ultrasound (TCD) to identify children with elevated cerebral blood flow velocity who (...) of hydroxyurea versus placebo to reduce central nervous system complications (abnormally fast blood flow to the brain, silent cerebral infarct or stroke) in young children with sickle cell disease. The investigators plan to identify children 12 to 48 months old without central nervous system complications and randomly assign 20 to treatment with hydroxyurea and 20 to treatment with placebo for 36 months. Neither the study doctors nor the participants will know which treatment they are receiving. Condition

2011 Clinical Trials

189. Ph I/II Study of Allogeneic SCT for Clinically Aggressive Sickle Cell Disease (SCD)

requiring emergency room visits Acute chest syndrome with recurrent hospitalizations, defined as ≥ 2 lifetime events Red-cell alloimmunization (≥ 2 antibodies) during longterm transfusion therapy Bilateral proliferative retinopathy with major visual impairment in at least one eye Osteonecrosis of 2 or more joints Sickle cell nephropathy Stage I or II sickle lung disease Symptoms of pulmonary hypertension and mean pulmonary artery pressure > 25mmHg Age 16-60 years Karnofsky performance status of 70 (...) still have aggressive disease despite hydroxyurea treatment. Hydroxyurea therapy also does not seem to prevent the development of pulmonary hypertension. In the pediatric population, patients that have not clinically improved despite optimized hydroxyurea management are offered allogeneic stem cell transplantation. Until recently, the options were more limited in adults with sickle cell disease that had aggressive disease despite hydroxyurea therapy. Most rely on chronic red blood cell transfusions

2011 Clinical Trials

190. A Study of HQK-1001 in Patients With Sickle Cell Disease

Study Description Go to Brief Summary: The purpose of this study is to evaluate the safety and tolerability of three dose levels of HQK-1001 administered once daily for 26 weeks in subjects with sickle cell disease. Condition or disease Intervention/treatment Phase Sickle Cell Disease Sickle Cell Anemia Sickle Cell Disorders Hemoglobin S Disease Sickling Disorder Due to Hemoglobin S Drug: HQK-1001 Phase 2 Study Design Go to Layout table for study information Study Type : Interventional (Clinical (...) , subject is able and willing to comply with necessary study procedures Exclusion Criteria: More than 4 hospitalizations for acute sickle cell related events in the previous 12 months prior to screening Pulmonary hypertension requiring oxygen therapy QTc > 450 msec (male) or 470 msec (female) on screening ECG (QT corrected by Fridericia's formula) Assigned to a regular transfusion program Use of erythropoiesis stimulating agents within 90 days of screening ALT > 3x upper limit of normal (ULN) Serum

2011 Clinical Trials

191. Safety and Pharmacokinetics of SANGUINATEâ„¢ in Sickle Cell Disease (SCD) Patients

terms Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn Blood Substitutes (...) pregnancy (β-HCG) test at screening and a negative urine pregnancy test at Day 0 prior to dosing. Female subjects must also be non-lactating; Adequate venous access and can receive intravenous infusions; Frequency of ER hospitalizations < 6x/yr for SCD pain events documented "medical history". Exclusion: In medical opinion of investigator, the patient is not an appropriate candidate; Patient is infected; The patient is Febrile; Patient has Acute chest syndrome or documented Sickle Cell Crisis; Patient

2011 Clinical Trials

192. Safety Study of MP4CO in Adult Sickle Cell Patients

by an inherited hemoglobin disorder. Healthy red blood cells are discoid and can deform and move through small blood vessels to carry oxygen to all parts of the body. In sickle cell disease, as red blood cells circulate and oxygen is released in the circulatory system, the deoxygenated abnormal hemoglobin S can begin to polymerize. When this occurs, the red blood cells can become sticky and elongated. These sickled red blood cells are less flexible and will obstruct small blood vessels and block normal red (...) blood cells from traveling through the circulatory system, which limits oxygen delivery to tissues and organs. This is known as a "sickle crisis". Patients suffering from a sickle crisis experience severe pain and are at risk of stroke, heart attack or even death. By lowering the level of oxygen pressure at which sickling occurs and opening the vasculature and rapidly delivering oxygen directly to ischemic tissues, the addition of MP4CO to existing treatment protocols may alleviate pain associated

2011 Clinical Trials

193. High levels of placenta growth factor in sickle cell disease promote pulmonary hypertension. Full Text available with Trip Pro

High levels of placenta growth factor in sickle cell disease promote pulmonary hypertension. Pulmonary hypertension is associated with reduced nitric oxide bioavailability and early mortality in sickle cell disease (SCD). We previously demonstrated that placenta growth factor (PlGF), an angiogenic factor produced by erythroid cells, induces hypoxia-independent expression of the pulmonary vasoconstrictor endothelin-1 in pulmonary endothelial cells. Using a lentivirus vector, we simulated (...) erythroid expression of PlGF in normal mice up to the levels seen in sickle mice. Consequently, endothelin-1 production increased, right ventricle pressures increased, and right ventricle hypertrophy and pulmonary changes occurred in the mice within 8 weeks. These findings were corroborated in 123 patients with SCD, in whom plasma PlGF levels were significantly associated with anemia, endothelin-1, and tricuspid regurgitant velocity; the latter is reflective of peak pulmonary artery pressure

2010 Blood

194. Paediatric sickle cell disease: pulmonary hypertension but normal vascular resistance. (Abstract)

Paediatric sickle cell disease: pulmonary hypertension but normal vascular resistance. Adults with sickle cell disease (SCD) and pulmonary hypertension have high mortality but death in SCD children with pulmonary hypertension is rare. The authors hypothesised that pulmonary hypertension in SCD children may be secondary to anaemia-induced high cardiac output rather than pulmonary vascular disease.Two independent, validated techniques were used to estimate pulmonary vascular resistance (PVR (...) with haemoglobin of the SS genotype (HbSS) versus 1/16 (6%) children with haemoglobin of the SC genotype (HbSC) had pulmonary hypertension (TRV≥2.5 m/s) (p=0.009). Right ventricular stroke volume was higher (p<0.05) and Doppler PVR lower (1.20 (0.19) vs 1.31 (0.20) Wood units, p=0.04) in SCD children with pulmonary hypertension compared with controls. Qpeff and stroke index were higher in SCD children compared with controls (p<0.001 for both) and correlated with anaemia (p<0.001) and TRV (p=0.03

2010 Archives of Disease in Childhood

195. Pulmonary Embolism (Diagnosis)

-modified albumin level White blood cell count Arterial blood gases: Serum troponin levels Brain natriuretic peptide Imaging studies Imaging studies that aid in the diagnosis of pulmonary embolism include the following: Computed tomography angiography (CTA): Multidetector-row CTA (MDCTA) is the criterion standard for diagnosing pulmonary embolism Pulmonary angiography: Criterion standard for diagnosing pulmonary embolism when MDCTA is not available Chest radiography: Abnormal in most cases of pulmonary (...) of pulmonary embolism by demonstrating the presence of a DVT at any site See for more detail. Management Anticoagulation and thrombolysis Immediate full anticoagulation is mandatory for all patients suspected of having DVT or pulmonary embolism. [ ] Diagnostic investigations should not delay empirical anticoagulant therapy. Thrombolytic therapy should be used in patients with acute pulmonary embolism who have hypotension (systolic blood pressure< 90 mm Hg) who do not have a high bleeding risk

2014 eMedicine.com

196. Pulmonary Embolism (Overview)

-modified albumin level White blood cell count Arterial blood gases: Serum troponin levels Brain natriuretic peptide Imaging studies Imaging studies that aid in the diagnosis of pulmonary embolism include the following: Computed tomography angiography (CTA): Multidetector-row CTA (MDCTA) is the criterion standard for diagnosing pulmonary embolism Pulmonary angiography: Criterion standard for diagnosing pulmonary embolism when MDCTA is not available Chest radiography: Abnormal in most cases of pulmonary (...) of pulmonary embolism by demonstrating the presence of a DVT at any site See for more detail. Management Anticoagulation and thrombolysis Immediate full anticoagulation is mandatory for all patients suspected of having DVT or pulmonary embolism. [ ] Diagnostic investigations should not delay empirical anticoagulant therapy. Thrombolytic therapy should be used in patients with acute pulmonary embolism who have hypotension (systolic blood pressure< 90 mm Hg) who do not have a high bleeding risk

2014 eMedicine.com

197. Pulmonary Embolism (Diagnosis)

-modified albumin level White blood cell count Arterial blood gases: Serum troponin levels Brain natriuretic peptide Imaging studies Imaging studies that aid in the diagnosis of pulmonary embolism include the following: Computed tomography angiography (CTA): Multidetector-row CTA (MDCTA) is the criterion standard for diagnosing pulmonary embolism Pulmonary angiography: Criterion standard for diagnosing pulmonary embolism when MDCTA is not available Chest radiography: Abnormal in most cases of pulmonary (...) of pulmonary embolism by demonstrating the presence of a DVT at any site See for more detail. Management Anticoagulation and thrombolysis Immediate full anticoagulation is mandatory for all patients suspected of having DVT or pulmonary embolism. [ ] Diagnostic investigations should not delay empirical anticoagulant therapy. Thrombolytic therapy should be used in patients with acute pulmonary embolism who have hypotension (systolic blood pressure< 90 mm Hg) who do not have a high bleeding risk

2014 eMedicine Emergency Medicine

198. Pulmonary Embolism (Overview)

-modified albumin level White blood cell count Arterial blood gases: Serum troponin levels Brain natriuretic peptide Imaging studies Imaging studies that aid in the diagnosis of pulmonary embolism include the following: Computed tomography angiography (CTA): Multidetector-row CTA (MDCTA) is the criterion standard for diagnosing pulmonary embolism Pulmonary angiography: Criterion standard for diagnosing pulmonary embolism when MDCTA is not available Chest radiography: Abnormal in most cases of pulmonary (...) of pulmonary embolism by demonstrating the presence of a DVT at any site See for more detail. Management Anticoagulation and thrombolysis Immediate full anticoagulation is mandatory for all patients suspected of having DVT or pulmonary embolism. [ ] Diagnostic investigations should not delay empirical anticoagulant therapy. Thrombolytic therapy should be used in patients with acute pulmonary embolism who have hypotension (systolic blood pressure< 90 mm Hg) who do not have a high bleeding risk

2014 eMedicine Emergency Medicine

199. Ultra-Low Dose IL-2 Therapy as GVHD Prophylaxis in Haploidentical Allogeneic Stem Cell Transplantation

of the study and provide informed consent. EXCLUSION CRITERIA DONOR (ANY OF THE FOLLOWING): Unfit to receive G-CSF and undergo apheresis such as abnormal blood counts, history of stroke, uncontrolled hypertension Sickling hemaglobinopathy including HbSS, HbAS, HbSC Donors who are positive for HIV, active hepatitis B (HBV), hepatitis C (HCV) or human T-cell lymphotropic virus (HTLV-I/II) Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the BMT treatment unlikely (...) Sponsor: National Heart, Lung, and Blood Institute (NHLBI) Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ) Study Details Study Description Go to Brief Summary: Background: - Stem cell transplantation from a partially matched donor can lead to graft-versus-host disease (GVHD). Researchers want to learn how to improve these transplantations. Objective: - To see if very low doses of Interleukin-2 after

2014 Clinical Trials

200. Effects of GSK1278863A on Pulmonary Artery Pressure in Healthy Volunteers

-containing products within 6 months prior to screening. Strong family history of malignancy. Subjects with sickle cell trait. History of pulmonary hypertension Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01673555 Locations Layout table for location (...) Effects of GSK1278863A on Pulmonary Artery Pressure in Healthy Volunteers Effects of GSK1278863A on Pulmonary Artery Pressure in Healthy Volunteers - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Effects

2012 Clinical Trials

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