[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100403365":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":30,"responsibleParty":48,"collaborators":18,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":18,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":18,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":18,"overallStatus":33,"whyStopped":18,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Children's Hospital of Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hydroxychloroquine","EXPERIMENTAL","Hydroxychloroquine in a dose of 10 mg\u002Fkg\\*d, p.o., bid for 12 months. The maximum daily dose is 400mg.",[13],"Drug: Hydroxychloroquine",{"label":15,"type":16,"description":17,"interventionNames":18},"control","NO_INTERVENTION","control group which do not take hydroxychloroquine for treatment.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"DRUG","Hydroxychloroquine Sulfate is an anti-malarial and anti-rheumatic drug. hydroxychloroquine has been reported to improve the clinical status of chILD cases wtih genetic causes. The exact mechanism of action of hydroxychloroquine is unknown. In additon to having anti-inflammatory properties, hydroxychloroquine has been shown to affect intracellular processing of surfactant protein.",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Liling Qian, Doctor","CONTACT","021-64931913","llqian@126.com",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Children's hospital of Fudan University","RECRUITING","Shanghai","Shanghai Municipality","201102","China","CN",{"type":40,"coordinates":41},"Point",[42,43],121.45806,31.22222,{"lat":43,"lon":42},[46],{"name":47,"role":27,"phone":28,"phoneExt":18,"email":29},"Ling Li Qian, Doctor",{"type":49,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100403365","early-phase-1-hydroxychloroquine-in-childrens-interstitial-lung-diseases-with-genetic-causes-100403365",false,"NCT04532346","Hydroxychloroquine in Children's Interstitial Lung Diseases With Genetic Causes","Safety and Efficacy of Hydroxychloroquine in Children's Interstitial Lung Diseases With Genetic Causes: a Randomized Controlled Study","Inclusion Criteria:\n\n* A clinical diagnosis of chILD with age\\\u003C18 years\n* Genetically diagnosed (e.g. SFTPC, SFTPB, ABCA3, NKX2-1, CSF2RA, CSF2RB, IARS, MARS, COPA, SLC7A7, LRBA)\n* Patients have to be clinically stable with no major changes in their medication in the last 4 weeks\n* No HCQ treatment in the last 12 weeks\n* Signed and dated informed consent of the subject (if subject has the ability) and the representatives (of underaged children) must be available before start of any specific trial procedures\n\nExclusion Criteria:\n\n* Acute severe infectious exacerbations\n* Known hypersensitivity to HCQ, or other ingredients of the tablets\n* Proven retinopathy or maculopathy\n* Renal insufficiency at screening, defined as glomerular filtration rate (GFR)\\\u003C 40 mL\u002Fmin\u002F1.73 m2 in patients aged 3 to 8 weeks\\\u003C 60 mL\u002Fmin\u002F1.73 m2 in patients ≥ 8 weeks of age\n* Participation in other clinical trials during the present clinical trial","ALL","1 Month","18 Years",{"count":61,"type":62},60,"ESTIMATED","INTERVENTIONAL",[65],"EARLY_PHASE1","The aim of this proposed study is to evaluate the efficacy and safety of hydroxychloroquine (HCQ) in children's interstitial lung diseases(chILD) with genetic causes. This study is a randomized controlled clinical trial.",[68,69],"Interstitial Lung Disease","Surfactant Dysfunction","2026-03-13",{"date":72,"type":73},"2026-03-16","ACTUAL",{"date":75,"type":73},"2024-09-01",{"date":77,"type":62},"2027-04",{"name":5,"class":6},1]