[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100436871":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":39,"centralContacts":40,"locations":46,"responsibleParty":64,"collaborators":39,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":39,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":49,"whyStopped":39,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group","EXPERIMENTAL","Oral dexamethasone (Neofordex®) 40 mg (Day1 to Day 4), ± an additional 4-days cycle of dexamethasone between days 10 and 21",[13],"Drug: Neofordex®",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","ACTIVE_COMPARATOR","IVIg (1g\u002Fkg D1-D2) plus prednisone (1 mg\u002Fkg\u002Fday x 21 days (3 weeks))",[19],"Drug: Intravenous immunoglobulins",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Neofordex®","Oral dexamethasone (Neofordex®) 40 mg (Day1 to Day 4), ± an additional 4-days cycle of dexamethasone between days 10 and 21.",[9],[27],"Dexamethasone",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Intravenous immunoglobulins","IVIg (1g\u002Fkg D1-D2) plus oral prednisone (1 mg\u002Fkg\u002Fday x 21 days (3 weeks))",[15],[33,34,35,36,37,38],"Tegeline®","Clayrig®,","Gammagard®,","Octagam®,","Privigen®,","Other IgIV patent medicine",null,[41],{"name":42,"role":43,"phone":44,"phoneExt":39,"email":45},"Matthieu MAHEVAS, MD,PhD","CONTACT","+33 (1) 49 81 20 76","matthieu.mahevas@aphp.fr",[47],{"facility":48,"status":49,"city":50,"state":39,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Henri Mondor Hospital","RECRUITING","Créteil","94010","France","FR",{"type":55,"coordinates":56},"Point",[57,58],2.46569,48.79266,{"lat":58,"lon":57},[61],{"name":62,"role":43,"phone":63,"phoneExt":39,"email":45},"Matthieu MAHEVAS, PHD","+33149812076",{"type":65,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100436871","phase-3-igiv-plus-prednisone-vs-high-dose-dexamethasone-for-itp-100436871",false,"NCT04968899","IgIV Plus Prednisone vs High-dose Dexamethasone for ITP","Intravenous Immunoglobulin Plus Oral Prednisone or High-dose Dexamethasone, for Adults With Immune Thrombocytopenia (ITP) With Moderate and Severe Bleeding: a Randomized, Multicentre Trial","IVIORDEX","Inclusion Criteria:\n\n* Age ≥ 18 years ≤ 80 years\n* Diagnosis of ITP whatever the duration of the disease (newly diagnosed or relapsed) according to the standard definition\n* Platelet count ≤ 20 x 109\u002FL\n* Any cutaneous and\u002For any mucosal bleeding manifestations\n* Affiliated to a social security regime\n* Written consent from patient\n\nExclusion Criteria:\n\n* Symptomatic COVID-19 disease\n* Life-threatening bleeding defined as Intracranial hemorrhage and\u002For active organ bleeding (GI tract, urinary tract or menorrhagia with at least a 2 g\u002Fdl decrease of hemoglobin value from baseline).\n* Ongoing anticoagulation treatment (Therapeutic Low molecular weight heparins (LMWHs), direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs))\n* Previous non-response to IVIg or DEX\n* Treatment with prednisone (1 mg\u002Fkg per day) for more than 3 days\n* Any, contraindications to the prescribed Ig IV or prednisone patent medicine and to Neofordex®\n* Ongoing severe infection\n* Severe Renal insufficiency (DFG \\\u003C 45 ml.min.1.73m2)\n* Severe Cardiac insufficiency (FEVG \\\u003C 30 %)\n* Ongoing viral infection (uncontrolled HIV, Viral hepatitis, herpes, varicella, zona).\n* Uncontrolled diabetes (Acido-cetosis)\n* Psychotic state not yet controlled by treatment\n* Inability or refusal to understand or refusal to sign the informed consent from study participation\n* Persons deprived of their liberty by judicial or administrative decision,\n* Persons under legal protection (guardianship, curatorship)\n* Pregnant or breastfeeding woman or ineffective contraception\n* Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants.","ALL","18 Years","80 Years",{"count":78,"type":79},272,"ESTIMATED","INTERVENTIONAL",[82],"PHASE3","ITP patients with low platelet count and active bleeding symptoms are at risk of life-threatening bleeding and therefore require a treatment with a rapid effect, reliable, and sustained. The combination of intravenous immunoglobulin (IVIg) and prednisone (1 mg\u002Fkg per day), is more rapidly and more frequently effective than high dose methylprednisolone to increase the platelet count. This combination is therefore usually given in patients with platelets count \\\u003C 20 x 109\u002FL and moderate to severe bleeding manifestations. Based on common practice in France and on French ITP guidelines, on average 50 % of patients with ITP and profound thrombocytopenia do actually receive IVIg (mostly during the initial phase of the disease) corresponding to approximately 1,500 ITP patients per year in France.\n\nWhereas IVIg is usually well tolerated, renal insufficiency and congestive heart failure may occur, moreover IVIg are costly and non-easily available with supply difficulties in many countries including France.\n\nHigh dose dexamethasone (DXM) (ie: 40 mg\u002Fd for 4 days) has recently emerged as a promising treatment for ITP. One recent meta-analysis as well as a controlled prospective trial suggest that the initial overall response was higher (\\> 80 %) and the time to response was shorter with dexamethasone (DXM) 40 mg\u002Fd given for 4 days compared to standard prednisone.\n\nThe investigators hypothesize that DXM could be a reasonable non-inferior alternative to IVIg, more convenient for patients with less adverse events and economically cost-effective for patients with moderate and severe bleeding manifestations.",[85],"Immune Thrombocytopenia (ITP)",[87,27,88,89],"Immune thrombocytopenia (ITP)","IntraVenous Immunoglobulin","Prednisone","2023-09-08",{"date":92,"type":93},"2023-09-11","ACTUAL",{"date":95,"type":93},"2022-04-07",{"date":97,"type":79},"2026-10-09",{"name":5,"class":6},1]