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Pulmonary Hypertension in Sickle Cell Anemia

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161. Study to Evaluate the Efficacy and Safety of GX-E2 in the Anemic Patients Diagnosed With Chronic Kidney Disease (CKD)

findings or previously taken chest x-ray findings Uncontrolled hypertension Congestive heart failure more severe than NYHA functional class III; unstable Coronary artery disease (CAD); myocardial infraction within 3 months Uncontrolled arrhythmia High risk of thrombosis and embolism Systemic blood diseases (e.g. Pure red cell anemia, sickle cell anemia, myelodysplastic syndromes, hematologic malignancy, myeloma, hemolytic anemia) Absolute neutrophil count below 1,500 per microliter (uL) within (...) Description: The secondary objective of study is to evaluate: change of red blood cell indices in anemic patients with chronic kidney disease receiving hemodialysis/peritoneal dialysis when administering GX-E2 intravenously/subcutaneously change of reticulocyte indices in anemic patients with chronic kidney disease receiving hemodialysis/peritoneal dialysis when administering GX-E2 intravenously/subcutaneously safety of GX-E2 when administering intravenously/subcutaneously incidence of blood transfusion

2014 Clinical Trials

162. Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease, on Dialysis

., chronic infectious hepatitis, chronic auto-immune liver disease, cirrhosis or fibrosis of the liver) Known hereditary hematologic disease such as thalassemia, sickle cell anemia, a history of pure red cell aplasia or other known causes for anemia other than CKD Known and untreated retinal vein occlusion or known and untreated proliferative diabetic retinopathy (risk for retinal vein thrombosis) Diagnosis or suspicion (e.g. complex kidney cyst of Bosniak Category IIF, III or IV) of renal cell carcinoma (...) on renal ultrasound (or other imaging procedure e.g. CT scan or MRI) conducted at screening or within 12 weeks prior to randomization. Uncontrolled hypertension at the time of randomization (defined as systolic BP ≥180 mmHg or diastolic BP ≥100 mmHg on repeated measurement post-dialysis in hemodialysis patients or at any time in peritoneal dialysis patients), contraindication to epoetin alfa treatment (e.g., pure red cell aplasia, hypersensitivity or know inability to tolerate epoetin alfa) History

2014 Clinical Trials

163. Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease (CKD), Not on Dialysis.

of the liver) Known hereditary hematologic disease such as thalassemia, sickle cell anemia, a history of pure red cell aplasia or other known causes for anemia other than CKD Known and untreated retinal vein occlusion or known and untreated proliferative diabetic retinopathy (risk for retinal vein thrombosis) Diagnosis or suspicion (e.g. complex kidney cyst of Bosniak Category IIF, III or IV) of renal cell carcinoma on renal ultrasound (or other imaging procedure e.g. CT scan or MRI) conducted at screening (...) : human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus antibody (anti-HCV Ab) Chronic inflammatory diseases such as rheumatoid arthritis, systemic lupus erythematosus (SLE), ankylosing spondylitis, psoriatic arthritis or inflammatory bowel disease that is determined to be the principal cause of anemia Known hemosiderosis, hemochromatosis or hypercoagulable condition Any prior organ transplant or a scheduled organ transplantation date Any red blood cell

2014 Clinical Trials

164. Evaluation of Efficacy and Safety of Roxadustat in the Treatment of Anemia in Stable Dialysis Subjects

(NYHA Class III or IV) Subject has had a heart attack, stroke, seizure, or a thrombotic/thromboembolic event (eg, DVT or pulmonary embolism) within 12 weeks prior to participating in the study Subject has uncontrolled high blood pressure within 2 weeks prior to participating in the study Subject has a history of malignancy, except for the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ (...) monthly IV Iron use per subject [ Time Frame: Weeks 1 to 36 ] Change from baseline in low density lipoprotein (LDL) [ Time Frame: Weeks 12 to 28 ] Change from baseline in SF-36 Physical Functioning (PF) sub-score [ Time Frame: Weeks 20 to 28 ] Change from baseline in SF-36 Vitality (VT) sub-score [ Time Frame: Weeks 20 to 28 ] Effect on predialysis blood pressure (BP) [ Time Frame: Weeks 1 to 36 ] Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate

2014 Clinical Trials

165. Phase 2 Study of MP4CO to Treat Vaso-occlusive Sickle Crisis

Description Go to Brief Summary: Sickle Cell disease is caused 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, the deoxygenated abnormal Hemoglobin S can begin to polymerize and cause red cells to become sticky and elongated. These "sickled" red cells are less flexible and will obstruct small blood vessels (...) may alleviate pain associated with a sickling crisis and potentially reduce the severity and duration of a crisis. This may shorten the time in hospital and potentially improve the quality of life for patients with sickle cell anemia. Condition or disease Intervention/treatment Phase Anemia, Sickle Cell Sickle Cell Anemia Sickle Cell Disease Sickle Cell Disorders Hemoglobin SC Disease Sickle Cell Hemoglobin C Disease Drug: MP4CO Drug: Sodium chloride solution Phase 2 Detailed Description: Sickle

2013 Clinical Trials

166. Anemia (Overview)

studies of purportedly healthy subjects show the prevalence of anemia to be 2-5 times greater than that in the United States. Although geographic diseases, such as sickle cell anemia, thalassemia, malaria, hookworm, and chronic infections, are responsible for a portion of the increase, nutritional factors with iron deficiency and, to a lesser extent, folic acid deficiency play major roles in the increased prevalence of anemia. Populations with little meat in the diet have a high incidence of iron (...) deficiency anemia, because heme iron is better absorbed from food than inorganic iron. Sickle cell disease is common in regions of Africa, India, Saudi Arabia, and the Mediterranean basin. The thalassemias are the most common genetic blood diseases and are found in Southeast Asia and in areas where sickle cell disease is common. Race-related demographics Certain races and ethnic groups have an increased prevalence of genetic factors associated with certain anemias. Diseases such as the hemoglobinopathies

2014 eMedicine.com

167. Anemia (Diagnosis)

studies of purportedly healthy subjects show the prevalence of anemia to be 2-5 times greater than that in the United States. Although geographic diseases, such as sickle cell anemia, thalassemia, malaria, hookworm, and chronic infections, are responsible for a portion of the increase, nutritional factors with iron deficiency and, to a lesser extent, folic acid deficiency play major roles in the increased prevalence of anemia. Populations with little meat in the diet have a high incidence of iron (...) deficiency anemia, because heme iron is better absorbed from food than inorganic iron. Sickle cell disease is common in regions of Africa, India, Saudi Arabia, and the Mediterranean basin. The thalassemias are the most common genetic blood diseases and are found in Southeast Asia and in areas where sickle cell disease is common. Race-related demographics Certain races and ethnic groups have an increased prevalence of genetic factors associated with certain anemias. Diseases such as the hemoglobinopathies

2014 eMedicine.com

168. Anemia, Acute (Diagnosis)

demise unless prompt resuscitative measures are taken. Marked tachycardia and significantly decreased blood pressure are common findings. Blood loss greater than 50% leads to loss of pulse and blood pressure. Urinary output is decreased in class III shock and is negligible in class IV shock. Patients with exacerbations of chronic anemia occasionally may present with signs and symptoms of congestive heart failure. Organomegaly is a common finding in patients with chronic blood disorders. A palpable (...) ) include anemias of chronic disease, iron deficiency, lead poisoning, and the hemoglobinopathies (ie, sickle cell disease, sideroblastic anemia, thalassemias). Normocytic anemias (MCV 80-100 fL) include anemias of acute blood loss, hemolysis, uremia, and cancer. Patients with early forms of microcytic anemia and multifactorial anemia may have normocytic MCVs. Macrocytic anemias (usually defined as MCV >100 fL) include anemias related to alcoholism, folate and vitamin B-12 deficiencies (pernicious

2014 eMedicine Emergency Medicine

169. Anemia, Acute (Overview)

demise unless prompt resuscitative measures are taken. Marked tachycardia and significantly decreased blood pressure are common findings. Blood loss greater than 50% leads to loss of pulse and blood pressure. Urinary output is decreased in class III shock and is negligible in class IV shock. Patients with exacerbations of chronic anemia occasionally may present with signs and symptoms of congestive heart failure. Organomegaly is a common finding in patients with chronic blood disorders. A palpable (...) ) include anemias of chronic disease, iron deficiency, lead poisoning, and the hemoglobinopathies (ie, sickle cell disease, sideroblastic anemia, thalassemias). Normocytic anemias (MCV 80-100 fL) include anemias of acute blood loss, hemolysis, uremia, and cancer. Patients with early forms of microcytic anemia and multifactorial anemia may have normocytic MCVs. Macrocytic anemias (usually defined as MCV >100 fL) include anemias related to alcoholism, folate and vitamin B-12 deficiencies (pernicious

2014 eMedicine Emergency Medicine

170. Anemia, Acute (Follow-up)

demise unless prompt resuscitative measures are taken. Marked tachycardia and significantly decreased blood pressure are common findings. Blood loss greater than 50% leads to loss of pulse and blood pressure. Urinary output is decreased in class III shock and is negligible in class IV shock. Patients with exacerbations of chronic anemia occasionally may present with signs and symptoms of congestive heart failure. Organomegaly is a common finding in patients with chronic blood disorders. A palpable (...) ) include anemias of chronic disease, iron deficiency, lead poisoning, and the hemoglobinopathies (ie, sickle cell disease, sideroblastic anemia, thalassemias). Normocytic anemias (MCV 80-100 fL) include anemias of acute blood loss, hemolysis, uremia, and cancer. Patients with early forms of microcytic anemia and multifactorial anemia may have normocytic MCVs. Macrocytic anemias (usually defined as MCV >100 fL) include anemias related to alcoholism, folate and vitamin B-12 deficiencies (pernicious

2014 eMedicine Emergency Medicine

171. Anemia, Acute (Treatment)

demise unless prompt resuscitative measures are taken. Marked tachycardia and significantly decreased blood pressure are common findings. Blood loss greater than 50% leads to loss of pulse and blood pressure. Urinary output is decreased in class III shock and is negligible in class IV shock. Patients with exacerbations of chronic anemia occasionally may present with signs and symptoms of congestive heart failure. Organomegaly is a common finding in patients with chronic blood disorders. A palpable (...) ) include anemias of chronic disease, iron deficiency, lead poisoning, and the hemoglobinopathies (ie, sickle cell disease, sideroblastic anemia, thalassemias). Normocytic anemias (MCV 80-100 fL) include anemias of acute blood loss, hemolysis, uremia, and cancer. Patients with early forms of microcytic anemia and multifactorial anemia may have normocytic MCVs. Macrocytic anemias (usually defined as MCV >100 fL) include anemias related to alcoholism, folate and vitamin B-12 deficiencies (pernicious

2014 eMedicine Emergency Medicine

172. Sickle Cell Disease

crises are treated with analgesics and other supportive measures. Transfusions are occasionally required. Vaccines against bacterial infections, prophylactic antibiotics, and aggressive treatment of infections prolong survival. Hydroxyurea may decrease the frequency of crises and the acute chest syndrome. Homozygotes (about 0.3% of blacks in the US) have sickle cell anemia; heterozygotes (8 to 13% of blacks) are typically not anemic but have an increased risk of other complications (...) crisis occurs when marrow erythropoiesis slows during acute infection due to human parvovirus, during which an acute erythroblastopenia may occur. Acute chest syndrome results from pulmonary microvascular occlusion and is a common cause of death, with mortality rates of up to 10%. It occurs in all age groups but is most common in childhood. Repeated episodes predispose to chronic . In children, acute sequestration of sickled cells in the spleen may occur, exacerbating anemia. , a serious complication

2013 Merck Manual (19th Edition)

173. Pulmonary vascular and ventricular dysfunction in the susceptible patient (2015 Grover Conference series) Full Text available with Trip Pro

aldosterone. Collectively, these mechanisms contribute to a contractile or hypertrophic pulmonary vascular phenotype. Genetically inherited disorders in hemoglobin structure are also an important etiology of abnormal pulmonary vasoreactivity. In sickle cell anemia, for example, consumption of the vasodilator and antimitogenic molecule nitric oxide by cell-free hemoglobin is an important mechanism underpinning pulmonary hypertension. Contemporary genomic and transcriptomic analytic methods have also (...) allowed for the discovery of novel risk factors relevant to sickle cell disease, including GALNT13 gene variants. In this report, we review cutting-edge observations characterizing these and other pathobiological mechanisms that contribute to pulmonary vascular and right ventricular vulnerability.

2016 Pulmonary circulation

174. Efficacy and Safety of Nintedanib When Co-administered With Sildenafil in Idiopathic Pulmonary Fibrosis Patients With Advanced Lung Function Impairment

at visit 1; Hypotension (systolic blood pressure [SBP] < 100 mm Hg or diastolic blood pressure [DBP] < 50 mm Hg) (symptomatic orthostatic hypotension) at visit 1; Uncontrolled systemic hypertension (SBP > 180 mmHg; or DBP > 100 mmHg) at visit 1; Known penile deformities or conditions (e.g., sickle cell anemia, multiple myeloma, leukemia) that may predispose to priapism; Retinitis pigmentosa; History of vision loss; History of nonarteritic ischemic optic neuropathy; Veno-occlusive disease; History (...) , signed prior to any study procedures being performed (including any required washout); Male or female patients aged >= 40 years at visit 1; A clinical diagnosis of IPF within the last 6 years before visit 1, based upon the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American thoracic Association 2011 guideline [P11-07084]; Combination of high-resolution computed tomography (HRCT) pattern, and if available, surgical lung biopsy pattern consistent

2016 Clinical Trials

175. Treprostinil Combined With Tadalafil for Pulmonary Hypertension

Thromboembolic Disease f. Sarcoidosis g. Pulmonary veno occlusive disease (PVOD) Concomitant use of nitrates (any form) either regularly or intermittently. Concomitant use of potent CYP3A inhibitors (e.g., ritonavir, ketoconazole, itraconazole) Vascular disease of the retina including retinitis pigmentosa, any sudden vision loss, including any damage to the optic nerve or NAION low blood pressure or high blood pressure that is not controlled Postural hypotension Inability to manage home infusion therapy (...) History of hypersensitivity reaction or adverse effect related to tadalafil Life expectancy < 12 months History of deformed penis shape, an erection that lasted more than 4 hours, or Peyronie's disease. Blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia Pregnant or planning to become pregnant or breast feed. 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

2011 Clinical Trials

176. DelIVery for Pulmonary Arterial Hypertension (PAH)

associated with hemoglobinopathies (sickle cell anemia, thalassemia), human immunodeficiency virus (HIV), schistosomiasis, portal hypertension, pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis Patient is implanted with electrical stimulation medical device(s) anywhere in the body (e.g., cardiac pacemakers, implantable cardioverter defibrillators (ICDs), spinal cord stimulators). This includes implanted leads and electrodes or abandoned leads and electrodes from an explanted device (...) Not Applicable Detailed Description: Pulmonary arterial hypertension (PAH) is a severe, chronic syndrome affecting the small pulmonary arteries (blood vessels which carry blood from the heart to the lungs to pick up oxygen). At the time of the initiation of this study, no cure exists for this disease. Medtronic has developed a fully implantable, long term, intravenous infusion system, which has the potential to enhance patient convenience and ease of use, while reducing the opportunities for catheter-related

2011 Clinical Trials

177. Ferinject® for Iron Deficiency in Idiopathic Pulmonary Arterial Hypertension (IPAH) Patients

Cardiovascular Diseases Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Anemia, Hypochromic Anemia Hematologic Diseases Iron Metabolism Disorders Metabolic Diseases Iron Trace Elements Micronutrients Nutrients Growth Substances Physiological Effects of Drugs (...) , ferritin or transferrin saturation) exceeds 1x upper limit of normal (ULN) in the local lab reference range. Patients with moderate to severe hypophosphatemia as defined as <0.65mmol/L Known to have haemoglobinopathy e.g. sickle cell disease, thalassaemia. Admission to hospital related to PAH or change in PAH therapy within 1 month prior to Screening. Evidence of left ventricular disease or significant lung disease on high-resolution CT scanning or lung function as judged by the investigator Acute

2011 Clinical Trials

178. Study to Evaluate the Safety, Efficacy and Pharmacokinetics of GSK1278863 in Japanese Hemodialysis-Dependent Subjects With Anemia Associated With Chronic Kidney Disease

impact erythropoiesis (e.g., scleroderma, systemic lupus erythematosis, rheumatoid arthritis, celiac disease) diagnosed prior to Screening 2 through Day 1. Hematological disease: Any hematological disease including those affecting platelets, white or red blood cells (e.g. sickle cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma, hemolytic anemia and thalassemia), coagulation disorders (e.g., antiphospholipid syndrome, Protein C or S deficiency), or any other cause of anemia (...) or acute coronary syndrome: Within the 8 weeks prior to Screening 2 through Day 1. Stroke or transient ischemic attack: Within the 8 weeks prior to Screening 2 through Day 1. Heart failure: Class III/IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system or symptomatic right heart failure diagnosed prior to Screening 2 through Day 1. Hypertension: Defined using pre-dialysis vitals of diastolic blood pressure >100 mmHg or systolic blood pressure >170 mmHg

2013 Clinical Trials

179. FG-4592 in the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa

to randomization. Subject has received any dose of IV iron within 6 weeks prior to randomization. Subject has received a Red Blood Cell (RBC) transfusion within 8 weeks prior to randomization. Subject has a known history of myelodysplastic syndrome or multiple myeloma. Subject has a known hereditary hematologic disease such as thalassemia or sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than Chronic Kidney Disease (CKD). Subject has a known hemosiderosis, hemochromatosis (...) vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization. Subject has one or more contraindications for treatment with darbepoetin alfa: Uncontrolled hypertension, or two or more blood pressure values of SBP greater than or equal to 160 mmHg or DBP greater than or equal to 95 mmHg (within 2 weeks prior to randomization). Known hypersensitivity to darbepoetin alfa, recombinant human erythropoietin, or any of the excipients. Subject has a diagnosis or suspicion (e.g., complex

2013 Clinical Trials

180. A Study to Evaluate Safety and Efficacy of GSK1278863 in Non-Dialysis Dependent (NDD) Subjects With Anemia Associated With Chronic Kidney Diseases (CKD)

-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 cell anemia, myelodysplastic syndromes, hematological (...) (CHr) at Week 24 [ Time Frame: Baseline and Week 24 ] Reticulocytes are slightly immature red blood cells. Reticulocyte Hgb content is used to differentiate iron deficiency from other causes of anemia. Baseline is the last pre-dose CHr value. Change from Baseline in reticulocyte Hgb was calculated by subtracting the Baseline value from the post-dose value. Change From Baseline in Hematocrit at Week 24 [ Time Frame: Baseline and Week 24 ] Baseline is the last pre-dose hematocrit value. Change from

2013 Clinical Trials

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