[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100366788":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":21,"studyPopulation":13,"armGroups":22,"interventions":33,"overallOfficials":41,"centralContacts":46,"locations":52,"responsibleParty":69,"collaborators":71,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":13,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":13,"enrollmentInfo":86,"targetDuration":13,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":13,"overallStatus":54,"whyStopped":13,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"EpiDestiny, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Blood Hemoglobin","Measure hemoglobin function","12 weeks",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"RANDOMIZED","PARALLEL","1:1 Randomization","TREATMENT",{"masking":20,"maskingDescription":13,"whoMasked":13},"NONE","A randomized control trial comparing oral THU-decitabine to nicotinamide (1:1 randomization), and then comparing the effects of the combination of nicotinamide with THU-decitabine vs either treatment alone. Treatment with each agent alone is for 12 weeks followed by the combination for a further 12 weeks. Patients have the option to enter an extension phase of combination treatment for an additional 24 weeks (total of 48 weeks)",[23,29],{"label":24,"type":25,"description":26,"interventionNames":27},"Nicotinamide","EXPERIMENTAL","Oral Nicotinamide 1000 mg twice daily",[28],"Drug: Nicotinamide",{"label":30,"type":25,"description":31,"interventionNames":32},"THU Decitabine","Oral 250 mg THU and 5 mg decitabine Once per week",[28],[34],{"type":35,"name":24,"description":36,"armGroupLabels":37,"otherNames":38},"DRUG","Oral nicotinamide (Vitamin B3) alone compared to THU Decitabine combination",[24,30],[39,40],"Decitabine","Tetrahydrouridine",[42],{"name":43,"affiliation":44,"role":45},"Robert Molokie","University of Illinois at Chicago College of Medicine","PRINCIPAL_INVESTIGATOR",[47],{"name":48,"role":49,"phone":50,"phoneExt":13,"email":51},"Lani Krauz","CONTACT","312-413-0242","LIgnacio@UIC.EDU",[53],{"facility":44,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"RECRUITING","Chicago","Illinois","60612","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-87.65005,41.85003,{"lat":64,"lon":63},[67],{"name":48,"role":49,"phone":50,"phoneExt":13,"email":68},"Llgnacio@UIC.EDU",{"type":70,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR",[72,75],{"name":73,"class":74},"National Institutes of Health (NIH)","NIH",{"name":76,"class":74},"National Heart, Lung, and Blood Institute (NHLBI)","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":87,"type":88},20,"ESTIMATED","INTERVENTIONAL",[91],"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).",[94],"Sickle Cell Disease","2026-09-26",{"date":97,"type":98},"2026-09-30","ACTUAL",{"date":100,"type":98},"2020-01-24",{"date":102,"type":88},"2029-01-20",{"name":5,"class":6},1]