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A Study to Evaluate Practical Anemia Bundle for SusTained Blood Recovery
Rochester, MN
The purpose of this research is to test a treatment plan to help reduce further anemia (a low blood count or hemoglobin level) and to promote hemoglobin and functional recovery in adults who have been in the intensive care unit (ICU).
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Clinical Trial Of Upfront Haploidentical Or Unrelated Donor Bmt To Restore Normal Hematopoiesis In Aplastic Anemia
Rochester, MN
The purpose of this study is to increase options for severe aplastic anemia, allowing HSCT to be considered as a potential treatment by using a novel GVHD prophylaxis strategy with PTCy that allows expansion of the donor pool to include haplo donors and unrelated donors (URDs).
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Allogeneic Stem Cell Transplantation for Patients with Severe Aplastic Anemia
Rochester, MN
For patients with severe aplastic anemia (SAA) who have failed to respond to immunosuppressive therapy and lack an HLA identical family member, our objectives are to make an initial assessment of the safety and efficacy of allogenic stem cell transplantation from either a matched unrelated donor or a mismatched reacted donor using the conditioning regimen of Cytoxan, reduced total body irradiation (TBI) and Campath IH. The principle measures of safety and efficacy will be :
- Patient survival probability at 100 days, 1 year and 2 years.
- Incidence of graft versus host disease (GVHD), as well as incidence of acute GVHD and chronic ...
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A Study Of AG-946 In Participants With Anemia Due To Lower-Risk Myelodysplastic Syndromes (LR-MDS)
Jacksonville, FL
The purpose of phase 2a is to establish proof-of-concept (POC) for AG-946 in participants with lower-risk myelodysplastic syndromes (LR-MDS) and to evaluate the safety, effect, and pharmacokineticsof AG-946 on additional measures of anemia. Additionally to evaluate the effect of AG-946 on transfusion burden (participants with LTB only) and the effect of AG-946 on pharmacodynamic biomarkers.
The purpose of phase 2b is to compare the effect of AG-946 versus placebo and to detect a doseresponse for erythroid response in participants with LR-MD
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A Safety Study Of SYNT001 In Subjects With Chronic, Stable Warm Autoimmune Hemolytic Anemia (WAIHA)
Rochester, MN
This study is being conducted to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and effects on warm autoimmune hemolytic anemia (WAIHA) disease activity markers of intravenous (IV) SYNT001.
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A Study To Measure Hemolysis Markers In Subjects With Warm Autoimmune Hemolytic Anemia
Rochester, MN
The purpose of this study is to measure and characterize markers of hemolysis (including but not limited to lactate dehydrogenase, indirect bilirubin, haptoglobin, and reticulocyte count), complement activation, and direct antiglobulin test (DAT), from subjects with Warm Autoimmune Hemolytic Anemia (wAIHA).
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Anemia Studies In Chronic Kidney Disease (CKD): Erythropoiesis Via A Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-in Incident Dialysis (ASCEND-ID)
Jacksonville, FL
The purpose of this multi-center study is to evaluate the efficacy and safety of daprodustat in subjects with anemia associated with CKD.
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Study Of DISC-0974 (RALLY-MF) In Participants With Myelofibrosis Or Myelodysplastic Syndrome And Anemia
Jacksonville, FL; Rochester, MN
This phase 1b/2a open-label study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of DISC-0974 as well as categorize the effects on hematologic response in participants with myelofibrosis or myelodysplastic syndrome and anemia.
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Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of ANX005 In Subjects With Warm Autoimmune Hemolytic Anemia (WAIHA)
Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of ANX005 in participants with Warm Autoimmune Hemolytic Anemia (wAIHA).
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Anemia Studies In Chronic Kidney Disease: Erythropoiesis Via A Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D)
Jacksonville, FL
The purpose of this multi-center event-driven study in participants with anemia associated with chronic kidney disease (CKD) to evaluate the safety and efficacy of daprodustat.
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Ruxolitinib Phosphate and Danazol in Treating Anemia in Patients with Myelofibrosis
Scottsdale/Phoenix, AZ
This phase II pilot trial studies how well ruxolitinib phosphate and danazol work in treating anemia in patients with myelofibrosis. Ruxolitinib phosphate and danazol may cause the body to make more red blood cells. They are used to treat anemia in patients with myelofibrosis.
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A Safety And Efficacy Study Of A Bowel Cleansing Preparation (BLI800) In Pediatric Subjects Undergoing Colonoscopy
Rochester, MN
The objective of this study is to compare the safety, tolerance and efficacy of BLI800 to a PEG based preparation prior to colonoscopy in adolescent patients.
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Study Of Rezafungin Compared To Standard Antimicrobial Regimen For Prevention Of Invasive Fungal Diseases In Adults Undergoing Allogeneic Blood And Marrow Transplantation (ReSPECT)
Rochester, MN
The primary objective of the United States Food and Drug Administration (FDA) for this study is to demonstrate non-inferiority in subjects who received an allogeneic BMT for subjects randomized to Rezafungin for Injection compared to subjects randomized to the standard antimicrobial regimen (SAR) for fungal-free survival at Day 90 (±7 days).
The primary objective of the European Medicines Agency (EMA) for this study is to demonstrate superiority in subjects who received an allogeneic BMT randomized to Rezafungin for Injection compared to subjects randomized to the SAR for fungal-free survival at Day 90 (±7 days).
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A Study To Evaluate Exercise For Cancer Patients At Risk Of Falling
Rochester, MN
The purpose of this study is to develop a data-driven approach that enables healthcare providers to “prescribe” exercise in the appropriate dose in a manner analogous to prescribing a drug.