[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"EpiDestiny, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":39},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"100366788","phase-1-a-study-of-nicotinamide-with-oral-tetrahydrouridine-and-decitabine-to-treat-high-risk-sickle-cell-disease-100366788",false,"NCT04055818","A Study of Nicotinamide With Oral Tetrahydrouridine and Decitabine to Treat High Risk Sickle Cell Disease","Proof-of-concept Study of Nicotinamide and Oral Tetrahydrouridine (THU) and Decitabine to Treat High Risk Sickle Cell Disease","Inclusion Criteria:\n\n* Age 18 years or older.\n* Written informed consent provided by the subject before study entry.\n* Confirmed sickle cell disease (SCD) as determined by hemoglobin electrophoresis or liquid chromatography.\n* Subject is in his\u002Fher steady state and not having any acute complication due to SCD (i.e., hospitalization, acute pain, or acute chest syndrome in the past 14 days).\n* Weight at least 40kg\n* Regular compliance with comprehensive care and previous therapy.\n* Symptomatic SCD is defined as having one of following, despite at least 6 months of hydroxyurea therapy, or refuse to take hydroxyurea for personal reasons: fetal hemoglobin \\\u003C0.5 g\u002FdL, or 3 or more pain episodes per year requiring parenteral narcotics, or 1 or more acute chest syndrome episodes, or Hemoglobin \\\u003C9 g\u002FdL and absolute reticulocyte count \\\u003C250,000\u002Fmm3.\n\nExclusion Criteria:\n\n* Inability to give informed consent.\n* Experienced severe sepsis or septic shock within the previous 12 weeks.\n* Last HU dose was ingested within the previous 4 weeks.\n* Currently pregnant or breast-feeding.\n* Alanine Aminotransferase (ALT) ≥ 3 times the upper limit of normal or albumin \\\u003C2.0 mg\u002FdL or direct (conjugated) bilirubin ≥ 1.5 mg\u002Fdl.\n* Serum creatinine \\>2.9 mg\u002FdL and calculated creatinine clearance \\\u003C30 mL\u002Fmin.\n* Platelet count \\>800 x 109\u002FL.\n* Absolute neutrophil count \\\u003C1.5 x 109\u002FL.\n* Female of active childbearing potential who is unwilling to use at least one of the two following forms of birth control: (i) not having heterosexual sexual contact beginning at the screening visit and continuing until 4 weeks after the last dose of decitabine OR (ii) intrauterine device (IUD).\n* Sexually active male who is unwilling to use a condom when engaging in any sexual contact with a female with child-bearing potential, beginning at the screening visit and continuing until 4 weeks after taking the last dose of THU and decitabine. This requirement applies also to males who have had a successful vasectomy.\n* Altered mental status or recurrent seizures requiring anti-seizure medications.\n* Moribund or any concurrent disease (e.g., hepatic, renal, cardiac, metabolic) of such severity that death within 24 weeks is likely.\n* Concurrent diagnosis of malignancy including known Myelodysplastic syndrome, leukemia, or an abnormal karyotype.\n* New York Heart Association (NYHA) class III\u002FIV status.\n* Eastern Co-operative Oncology Group (ECOG) performance status ≥3.\n* Participant is on chronic transfusion therapy\n* Known history of illicit drug or alcohol abuse within the past 12 months.\n* Other experimental or investigational drug therapy in the past 28 days.\n* Taking l-glutamine within the last 28 days\n* Being positive for HIV infection","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","A randomized control trial in 20 subjects with sickle cell disease comparing oral THU-decitabine to nicotinamide and in combination (THU, decitabine and nicotinamide).",[26],"Sickle Cell Disease","RECRUITING","2026-09-26",{"date":30,"type":31},"2026-09-30","ACTUAL",{"date":33,"type":31},"2020-01-24",{"date":35,"type":20},"2029-01-20",{"name":37,"class":38},"EpiDestiny, Inc.","INDUSTRY",""]