[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100407736":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":103,"collaborators":105,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":116,"sex":122,"minAge":123,"maxAge":24,"enrollmentInfo":124,"targetDuration":24,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":57,"whyStopped":24,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"University of Aarhus","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients treated with immunoglobulin intravenously (IVIG)","ACTIVE_COMPARATOR","Immunoglobulin (PRIVIGEN) intravenously 2 g\u002Fkg\u002F4week for 26 weeks. After this 60 weeks of reduction every 12 weeks (90%, 75%, 50%, 25% and 0%).",[13],"Biological: Immunoglobulin",{"label":15,"type":10,"description":16,"interventionNames":17},"Patients treated with immunoglobulin subcutaneously (SCIG)","Immunoglobulin (HIZENTRA) subcutaneously 0.54 g\u002Fkg\u002Fweek for 26 weeks. After this 60 weeks of reduction every 12 weeks (90%, 75%, 50%, 25% and 0%).",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"BIOLOGICAL","Immunoglobulin","Randomization 1:1 to the same total dose of either SCIG or IVIG for 26 weeks of stable dose + 60 weeks of redcution.",[9,15],null,[26],{"name":27,"affiliation":28,"role":29},"Henning Andersen, MD,DMSc,PhD","Aarhus University, Aarhus University Hospital","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":24,"email":35},"Lars Markvardsen, MD, PhD","CONTACT","+45 20231903","larsmark@rm.dk",[37,55,75,89],{"facility":38,"status":39,"city":40,"state":24,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Department of Neurology, Aalborg University Hospital","NOT_YET_RECRUITING","Aalborg","9000","Denmark","DK",{"type":45,"coordinates":46},"Point",[47,48],9.9187,57.048,{"lat":48,"lon":47},[51],{"name":52,"role":33,"phone":53,"phoneExt":24,"email":54},"Izabella Obál, Md, PhD","9766 2200","i.obal@rn.dk",{"facility":56,"status":57,"city":58,"state":24,"zip":59,"country":42,"countryCode":43,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Department of Neurology, Aarhus University Hospital","RECRUITING","Aarhus C","8000",{"type":45,"coordinates":61},[62,63],10.21231,56.16558,{"lat":63,"lon":62},[66,69,72,74],{"name":67,"role":33,"phone":24,"phoneExt":24,"email":68},"Henning Andersen, DMSc","hennande@rm.dk",{"name":70,"role":33,"phone":71,"phoneExt":24,"email":35},"Lars Markvardsen, MD","+45 7846 3337",{"name":70,"role":73,"phone":24,"phoneExt":24,"email":24},"SUB_INVESTIGATOR",{"name":67,"role":29,"phone":24,"phoneExt":24,"email":24},{"facility":76,"status":39,"city":77,"state":24,"zip":78,"country":42,"countryCode":43,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Department of Neurology, Rigshospitalet, Copenhagen University Hospital","Copenhagen","2100",{"type":45,"coordinates":80},[81,82],12.56553,55.67594,{"lat":82,"lon":81},[85,88],{"name":86,"role":33,"phone":24,"phoneExt":24,"email":87},"Tina D Jeppesen, MD,DMSc,PhD","tina.dysgaard.jeppesen@regionh.dk",{"name":86,"role":29,"phone":24,"phoneExt":24,"email":24},{"facility":90,"status":39,"city":91,"state":24,"zip":92,"country":42,"countryCode":43,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Department of Neurology, Odense University Hospital","Odense","5000",{"type":45,"coordinates":94},[95,96],10.38831,55.39594,{"lat":96,"lon":95},[99],{"name":100,"role":33,"phone":101,"phoneExt":24,"email":102},"Søren Sindrup, MD, DMSc","+45 6541 2485","soeren.sindrup@rsyd.dk",{"type":104,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[106,108,110,112],{"name":107,"class":6},"Rigshospitalet, Denmark",{"name":109,"class":6},"Aarhus University Hospital",{"name":111,"class":6},"Odense University Hospital",{"name":113,"class":6},"Aalborg University Hospital","100407736","phase-4-subcutaneous-immunoglobulin-in-de-novo-cidp-sidec-100407736",false,"NCT04589299","Subcutaneous Immunoglobulin in De-novo CIDP (SIDEC)","Randomized, Parallel Study of Subcutaneous Versus Intravenous Immunoglobulin in Treatment-naïve Patients With Chronic Inflammatory Demyelinating Polyneuropathy","SIDEC","Inclusion Criteria:\n\n* Fulfilling EFNS\u002FPNS criteria for definite, probable or pure motor CIDP.\n* No previous treatment with IVIG or SCIG.\n* Age ≥ 18.\n* ODSS ≥ 2 - either (arm\u002Fleg): 1\u002F1, 2\u002F0 or 0\u002F2 at the time of inclusion.\n\nClinical criteria for typical CIDP\n\n* Chronically progressive, stepwise, or recurrent symmetric proximal and distal weakness and sensory dysfunction of all extremities, developing over at least 2 months; cranial nerves may be affected.\n* Absent or reduced tendon reflexes in all extremities.\n\nCriteria for pure motor CIDP • Pure motor affection; otherwise as for typical CIDP.\n\nElectrophysiological criteria for CIDP\n\n1. Motor distal latency prolongation ≥50% above ULN in two nerves (excluding median neuropathy at the wrist from carpal tunnel syndrome), or\n2. Reduction of motor conduction velocity ≥30% below LLN in two nerves, or\n3. Prolongation of F-wave latency ≥30% above ULN in two nerves (≥50% if amplitude of distal negative peak CMAP ≤80% of LLN values), or\n4. Absence of F-waves in two nerves of these nerves have distal negative peak CMAP amplitudes ≥20% of LLN + ≥1 other demyelinating parameter in ≥1 other nerve, or\n5. Partial motor conduction block: ≥50% amplitude reduction of the proximal negative peak CMAP relative to distal, if distal negative peak CMAP \\>20% of LLN, in two nerves, or in one nerve + ≥1 other demyelinating parameter in ≥1 other nerve, or\n6. Abnormal dispersion (≥30% duration increase between the proximal and distal negative peak CMAP) in ≥2 nerves, or\n7. Distal CMAP duration (interval between onset of the first negative peak an return to baseline of the last negative peak) increase in ≥1 nerve (median ≥6.6 ms, ulnar ≥6.7 ms, peroneal ≥7.6 ms, tibial ≥8.8 ms) + ≥1 other demyelinating parameter in ≥1 other nerve\n\nElectrophysiological criteria for probable CIDP\n\n(a) ≥30% amplitude reduction of the proximal negative peak CMAP relative to distal, excluding the posterior tibial nerve, if distal negative peak CMAP ≥20% of LLN, in two nerves, or in one nerve + ≥1 other demyelinating parameter in ≥1 other nerve\n\nExclusion Criteria:\n\n* Other causes of neuropathy\n* Increased risk of thromboembolism\n* Pregnancy (Plasma HCG is tested at inclusion in all fertile women)\n* Breast feeding\n* Malignancy\n* Severe medical disease\n* Other immune modulating treatment than low dose steroid (prednisolon \\\u003C 25 mg daily) within the last 6 months prior to inclusion\n* Hepatitis B or C or HIV infection (screening at inclusion)\n* Known IgA deficiency\n* Known allergy to consents in PRIVIGEN or HIZENTRA\n* Body weight \\> 120 kg\n\nAfter treatment initiation:\n\n* Pregnancy\n* Serious medical disease that affects treatment or examinations\n* Non-compliance to treatment\n* Initiation of other immune modulating therapy\n* Unacceptable side effects\n* Withdrawal of consent to participate (drop-out)","ALL","18 Years",{"count":125,"type":126},60,"ESTIMATED","INTERVENTIONAL",[129],"PHASE4","SIDEC - (Subcutaneous Immunoglobulin in De-novo CIDP) ia a study designed as a randomized, parallel study with an open-label extension phase. The aims are to compare the effect of SCIG and IVIG in 60 treatment-naïve CIDP patients, and to detect the lowest effective dosage for maintenance treatment.",[132],"CIDP - Chronic Inflammatory Demyelinating Polyneuropathy",[134,135],"Immunoglobulins, Intravenous","Injections, Subcutaneous","2024-05-15",{"date":138,"type":139},"2024-05-17","ACTUAL",{"date":141,"type":139},"2020-06-04",{"date":143,"type":126},"2030-12-31",{"name":5,"class":6},4]