[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531354":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":33,"centralContacts":37,"locations":43,"responsibleParty":210,"collaborators":212,"id":216,"slug":217,"hasResults":218,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":218,"sex":224,"minAge":225,"maxAge":226,"enrollmentInfo":227,"targetDuration":32,"studyType":230,"phases":231,"briefSummary":233,"conditions":234,"keywords":32,"overallStatus":115,"whyStopped":32,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":246},{"fullName":5,"class":6},"Novo Nordisk A\u002FS","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1: Etavopivat (12 to less than [\u003C] 18 years)","EXPERIMENTAL","Participants aged 12 to less than 18 years with sickle cell disease will receive etavopivat to evaluate pharmacokinetics and safety in this age group.",[13],"Drug: Etavopivat",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2: Etavopivat (6 to \u003C12 years)","Participants aged 6 to less than 12 years with sickle cell disease will receive etavopivat to evaluate pharmacokinetics and safety in this age group.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort 3: Etavopivat (2 to \u003C6 years)","Participants aged 2 to less than 6 years with sickle cell disease will receive etavopivat to evaluate pharmacokinetics and safety in younger children.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Cohort 4: Etavopivat (6 months to \u003C2 years)","Participants aged 6 months to less than 2 years with sickle cell disease will receive etavopivat to evaluate pharmacokinetics and safety in infants.",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Etavopivat","Participants will receive oral tablets or granules of etavopivat once daily.",[9,15,19,23],null,[34],{"name":35,"affiliation":5,"role":36},"Clinical Transparency (dept. 2834)","STUDY_DIRECTOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":32,"email":42},"Novo Nordisk","CONTACT","(+1) 866-867-7178","clinicaltrials@novonordisk.com",[44,58,70,79,83,95,104,113,120,131,140,147,156,165,175,184,195,201],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":32},"The Hospital for Sick Children","COMPLETED","Toronto","Ontario","M5G 1X8","Canada","CA",{"type":53,"coordinates":54},"Point",[55,56],-79.39864,43.70643,{"lat":56,"lon":55},{"facility":59,"status":60,"city":61,"state":32,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":69,"contacts":32},"HCL-HOPITAL LYON SUD_Institut d'Hématologie et d'Oncologie Pédiatrique (IHOPe)","NOT_YET_RECRUITING","Lyon","69008","France","FR",{"type":53,"coordinates":66},[67,68],4.84789,45.74906,{"lat":68,"lon":67},{"facility":71,"status":60,"city":72,"state":32,"zip":73,"country":63,"countryCode":64,"cosmosGeoPoint":74,"geoPoint":78,"contacts":32},"APHP - Centre de Référence des Syndromes","Paris","75019",{"type":53,"coordinates":75},[76,77],2.3488,48.85341,{"lat":77,"lon":76},{"facility":80,"status":60,"city":81,"state":32,"zip":82,"country":63,"countryCode":64,"cosmosGeoPoint":32,"geoPoint":32,"contacts":32},"Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle","Roeun","76031",{"facility":84,"status":60,"city":85,"state":86,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":94,"contacts":32},"KEMRI CRDR Siaya Clinical Research Annex, Country Referral Hospital","Siaya","Siaya County","40600","Kenya","KE",{"type":53,"coordinates":91},[92,93],34.28806,0.0607,{"lat":93,"lon":92},{"facility":96,"status":60,"city":97,"state":32,"zip":98,"country":88,"countryCode":89,"cosmosGeoPoint":99,"geoPoint":103,"contacts":32},"KEMRI-Walter-Reed Kericho","Kericho","20200",{"type":53,"coordinates":100},[101,102],35.28314,-0.36774,{"lat":102,"lon":101},{"facility":105,"status":60,"city":106,"state":32,"zip":107,"country":88,"countryCode":89,"cosmosGeoPoint":108,"geoPoint":112,"contacts":32},"Kombewa Clinical Research Centre","Kisumu","40100",{"type":53,"coordinates":109},[110,111],34.76171,-0.10221,{"lat":111,"lon":110},{"facility":114,"status":115,"city":106,"state":32,"zip":116,"country":88,"countryCode":89,"cosmosGeoPoint":117,"geoPoint":119,"contacts":32},"Ahero Clinical Trials Unit","RECRUITING","40101",{"type":53,"coordinates":118},[110,111],{"lat":111,"lon":110},{"facility":121,"status":115,"city":122,"state":32,"zip":123,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":130,"contacts":32},"American University of Beirut Medical center","Beirut","1107 2020","Lebanon","LB",{"type":53,"coordinates":127},[128,129],35.50157,33.89332,{"lat":129,"lon":128},{"facility":132,"status":115,"city":133,"state":32,"zip":134,"country":124,"countryCode":125,"cosmosGeoPoint":135,"geoPoint":139,"contacts":32},"Hospital Nini","Tripoli","113-6044",{"type":53,"coordinates":136},[137,138],35.84415,34.43352,{"lat":138,"lon":137},{"facility":141,"status":115,"city":142,"state":143,"zip":144,"country":145,"countryCode":146,"cosmosGeoPoint":32,"geoPoint":32,"contacts":32},"University of Nigeria Teaching Hospital (UNTH)","Ituku-Ozalla","Enugu State","400001","Nigeria","NG",{"facility":148,"status":115,"city":149,"state":32,"zip":150,"country":145,"countryCode":146,"cosmosGeoPoint":151,"geoPoint":155,"contacts":32},"Lagos University Teaching Hospital, Lagos","Lagos","102215",{"type":53,"coordinates":152},[153,154],3.39467,6.45407,{"lat":154,"lon":153},{"facility":157,"status":115,"city":158,"state":32,"zip":159,"country":145,"countryCode":146,"cosmosGeoPoint":160,"geoPoint":164,"contacts":32},"Aminu Kano Teaching Hospital (AKTH)","Tarauni","700101",{"type":53,"coordinates":161},[162,163],8.90009,12.11098,{"lat":163,"lon":162},{"facility":166,"status":46,"city":167,"state":32,"zip":168,"country":169,"countryCode":32,"cosmosGeoPoint":170,"geoPoint":174,"contacts":32},"Hacettepe University pediatric hematology","Ankara","06100","Turkey (Türkiye)",{"type":53,"coordinates":171},[172,173],32.85427,39.91987,{"lat":173,"lon":172},{"facility":176,"status":46,"city":177,"state":32,"zip":178,"country":169,"countryCode":32,"cosmosGeoPoint":179,"geoPoint":183,"contacts":32},"Acıbadem Adana Hastanesi","Seyhan","1130",{"type":53,"coordinates":180},[181,182],35.30592,36.98747,{"lat":182,"lon":181},{"facility":185,"status":115,"city":186,"state":32,"zip":187,"country":188,"countryCode":189,"cosmosGeoPoint":190,"geoPoint":194,"contacts":32},"Guys and St Thomas NHS Foundation Trust \u002F Evelina Childrens Hospital","London","SE1 7EH","United Kingdom","UK",{"type":53,"coordinates":191},[192,193],-0.12574,51.50853,{"lat":193,"lon":192},{"facility":196,"status":115,"city":186,"state":32,"zip":197,"country":188,"countryCode":189,"cosmosGeoPoint":198,"geoPoint":200,"contacts":32},"King's College Hospital - Alex Mowat Research Hub","SE5 9RS",{"type":53,"coordinates":199},[192,193],{"lat":193,"lon":192},{"facility":202,"status":115,"city":203,"state":32,"zip":204,"country":188,"countryCode":189,"cosmosGeoPoint":205,"geoPoint":209,"contacts":32},"Manchester Royal Infirmary_1","Manchester","M13 9WL",{"type":53,"coordinates":206},[207,208],-2.23743,53.48095,{"lat":208,"lon":207},{"type":211,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[213],{"name":214,"class":215},"Novo Nordisk A\u002FS. This study is currently undergoing a sponsor transition from Forma Therapeutics, Inc. to Novo Nordisk A\u002FS.","UNKNOWN","100531354","phase-2-a-study-to-evaluate-the-pharmacokinetics-and-safety-of-etavopivat-in-pediatric-patients-with-sickle-cell-disease-100531354",false,"NCT06198712","A Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients With Sickle Cell Disease","A Single Arm, Open Label, Phase 1\u002F2 Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients With Sickle Cell Disease","HIBISCUS KIDS","Inclusion Criteria:\n\n* Type of Participant and Disease Characteristics\n\n  1. Patient's parent, legal guardian, or legal representative has provided documented informed consent and patients have provided age-appropriate assent\n  2. Age greater than or equal to (≥) 6 months and lesser than (\\\u003C) 18 years of age at time of enrollment, according to the enrolling cohort:\n\n     * Cohort 1: age 12 to \\\u003C 18 years (adolescents)\n     * Cohort 2: age 6 to \\\u003C 12 years\n     * Cohort 3: age 2 to \\\u003C 6 years\n     * Cohort 4: age 6 months to \\\u003C 2 years\n  3. Patient has confirmed diagnosis of SCD\n\n     • Documentation of SCD genotype (HbSS, HbSβ0-thalassemia or other sickle cell syndrome variants) based on prior history of laboratory testing. Molecular genotyping is not required. SCD genotype may be determined from the results of Hb electrophoresis, high-performance liquid chromatography (HPLC), or similar testing. Note that Hb electrophoresis is performed by the local laboratory at Screening.\n  4. Hemoglobin ≥ 5.5 and lesser than or equal to (≤) 10.5 grams per deciliter (g\u002FdL)\n  5. Pediatric patients with severe SCD, as defined by at least 1 of the following:\n\n     * 2-15 episodes of documented VOC within the 12 months prior to screening. Documentation must exist in the patient's medical record prior to screening. Events based solely on patient recall without supporting documentation should not be counted towards eligibility.\n     * Hospitalization for any SCD-related complication in the last 12 months prior to starting study treatment\n     * Proteinuria, defined as an albumin:creatinine ratio (ACR) \\> 100 mg\u002Fg on 2 measures (separated by ≥ 1 month) as an indicator of early renal disease\n     * History of a conditional TCD in the last 12 months prior to starting study treatment, but not currently being treated with chronic transfusion therapy (applicable to participants \\> 2 years of age). Conditional TCD is defined as a TAMMV of 170-199 cm\u002Fs by TCD or 155-184 cm\u002Fs by imaging TCD (TCDi).\n  6. For participants taking hydroxyurea (HU), the dose of HU (mg\u002Fkg) must be stable (no more than a 20% change in dosing) for at least 90 days prior to start of study treatment with no anticipated need for dose adjustments during the study, in the opinion of the Investigator\n  7. Patients on crizanlizumab or L-glutamine treatment at the time of consent may be eligible if they:\n\n     * Have been on a stable dose for ≥ 12 months at the time of consent (ie, no changes to the dose except for changes to weight or for safety reasons)\n     * For patients on crizanlizumab, have been ≥ 80% compliant with the planned regimen during the 12 months prior to the time of consent\n  8. Female patients of childbearing potential who are using acceptable methods of contraception and agree not to donate ova from study start to 90 days after the last dose of study drug, and male patients who are willing to use acceptable methods of contraception and agree not to donate sperm, from study start to 90 days after the last dose of study drug.\n\nExclusion Criteria:\n\n* Medical Conditions\n\n  1. Female who is breastfeeding or pregnant\n  2. More than 15 VOCs within the 12 months prior to starting study treatment that required a hospital, emergency room (ER), or clinic visit\n  3. Hospitalized for sickle cell crisis or other vaso-occlusive event occurring in the 14 days prior to starting study treatment\n  4. Abnormal TCD in the 12 months prior to starting study treatment\n\n     Prior\u002FConcomitant Therapy\n  5. Patients receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion)\n  6. Received any blood products within 30 days of starting study treatment\n  7. Receiving or use of concomitant medications that are strong inducers of cytochrome P450 (CYP) 3A4\u002F5 within 2 weeks of starting study treatment\n  8. Use of voxelotor within 28 days prior to starting study treatment or anticipated need for this agent during the study\n  9. Receipt of erythropoietin or other hematopoietic growth factor treatment within 28 days of starting study treatment or anticipated need for such agents during the study\n  10. Receipt of prior cellular based therapy (eg, hematopoietic cell transplant, gene modification therapy)","ALL","6 Months","18 Years",{"count":228,"type":229},95,"ESTIMATED","INTERVENTIONAL",[232],"PHASE2","The purpose of this study is to evaluate the pharmacokinetics and safety of etavopivat in paediatric participants with sickle cell disease (SCD). Participants will receive etavopivat and will be enrolled in a staggered manner, starting with the oldest age group and followed sequentially by younger cohorts after review of pharmacokinetic and safety data from the preceding cohort. All participants will undergo a 24-week primary treatment period followed by a 72-week extension treatment period to further evaluate long-term safety and pharmacokinetics of etavopivat. The total duration of the study will be approximately 96 weeks.",[235],"Sickle Cell Disease","2026-08-07",{"date":238,"type":239},"2026-08-12","ACTUAL",{"date":241,"type":239},"2023-01-12",{"date":243,"type":229},"2029-08-08",{"name":245,"class":6},"Forma Therapeutics, Inc.",18]