38. スティーヴンス・ジョンソン症候群 Stevens-Johnson syndrome Clinical trials / Disease details


臨床試験数 : 13 薬物数 : 23 - (DrugBank : 9) / 標的遺伝子数 : 15 - 標的パスウェイ数 : 101

  
No.TrialIDDate_
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PhaseCountries
1NCT02987257
(ClinicalTrials.gov)
March 15, 202225/11/2016NATIENS: Optimal Management and Mechanisms of SJS/TENNATIENS: A Phase III Randomized Double-Blinded Placebo Controlled Study to Determine the Optimal Management and Mechanisms of Stevens-Johnson Syndrome and Toxic Epidermal NecrolysisStevens-Johnson Syndrome;Toxic Epidermal NecrolysesDrug: Harmonized supportive care;Drug: Cyclosporine 5 mg/kg bid days 0-14;Drug: Etanercept 50 mg sc day 0 and day 3Vanderbilt University Medical CenterUniversity of Ottawa;University of TorontoNot yet recruiting18 YearsN/AAll267Phase 3United States
2JPRN-jRCTs031210325
01/10/202117/09/2021Etanercept therapy for Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) cases of refractory to systemic steroid therapyopen-label, multicenter, single-arm study to evaluate the efficacy and safety of etanercept in patients with Stevens-Johnson syndrome and toxic epidermal necrolysis who were ineffective with systemic steroid therapy stevens-johnson syndrome, toxic epidermal necrosis
stevens-johnson syndrome, toxic epidermal necrosis
Etanercept 50 mg / day is subcutaneously administered on the first day (Day 1). If epithelialization is not complete, administer once on day 8 (Day 8) and day 15 (Day 15) as needed.Abe RiichirouNULLRecruiting>= 20age oldNot applicableBoth10Phase 2Japan
3EUCTR2020-003544-83-FR
(EUCTR)
16/03/202108/01/2021Evaluation de l’efficacité thérapeutique du filgrastim dans les allergies sévères bulleuses aux médicaments s’exprimant sous forme de Lyell et Stevens-Johnson Etude GNETEvaluation de l’efficacité thérapeutique du filgrastim dans les allergies sévères bulleuses aux médicaments s’exprimant sous forme de Lyell et Stevens-Johnson Etude GNET Syndrome de Stevens Johnson (SJS)Syndrome de Lyell (NET)
MedDRA version: 20.1;Level: LLT;Classification code 10042030;Term: Stevens Johnson syndrome;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10025166;Term: Lyell syndrome;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: ZARZIO
INN or Proposed INN: FILGRASTIM
Hospices Civils de Lyon - Direction de la Recherche CliniqueNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 2;Phase 3France
4NCT03585946
(ClinicalTrials.gov)
January 1, 202114/3/2018Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal NecrolysisA Prospective Multicenter Cohort Study Assessing Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal NecrolysisStevens-Johnson Syndrome;Toxic Epidermal Necrolysis;Drug ReactionDrug: Site specific standard of care comparisonMassachusetts General HospitalNULLNot yet recruiting18 YearsN/AAll750NULL
5JPRN-jRCTs061180044
01/06/201712/03/2019Multicenter Open-trial of Steroid pulse therapy for SJS/TENMulticenter Open-trial of Steroid pulse therapy for SJS/TEN - MOSST Study Stevens-Johnson syndrome and Toxic epidermal necrolysis1. infusion of methylprednisolone at 500~1000 mg/d
(0.9% N/S in 3 hour) for 3 consecutive days.
2. Oral predonisolone (0.5 mg/kg/d) was initiated on the
day following the last dose of methylprednisolone, and
prednisolone was subsequently tapered within 2 weeks.
If the ocular involvement score is more than 2, dose of
oral predonisolone (1 mg/kg/d) is recommended.
Morita EishinNULLComplete>= 20age old<= 90age oldBoth20Phase 2Taiwan;Germany;Japan
6NCT02126020
(ClinicalTrials.gov)
November 201427/4/2014Topical Infliximab in Autoimmune Eyes With KeratoprosthesisTopical Infliximab in Autoimmune Eyes With KeratoprosthesisStevens-Johnson Syndrome;Toxic Epidermal Necrolysis (Lyell) Syndrome;Mucous Membrane PemphigoidDrug: topical infliximabJames Chodosh, MD, MPHMassachusetts Eye and Ear Infirmary;Fonds de recherche en ophtalmologie de l'Université de Montréal (FROUM)Withdrawn18 Years80 YearsAll0Phase 1/Phase 2United States;Canada
7NCT02149732
(ClinicalTrials.gov)
May 201414/5/2014Clinical Trial on the Effect of Autologous Oral Mucosal Epithelial Sheet TransplantationAn Investigator-initiated Trial (IIT) on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation in Corneal Limbal Deficiency PatientsLimbal Stem Cell Deficiency;Stevens-johnson Syndrome;Ocular Cicatricial Pemphigoid;Chemical BurnBiological: cultivated oral mucosal epithelial sheet transplantationSeoul National University HospitalMinistry of Health & Welfare, KoreaAvailable16 YearsN/ABothPhase 1/Phase 2Korea, Republic of
8EUCTR2012-003136-23-GB
(EUCTR)
27/11/201216/11/2012Lamotrigine And Borderline Personality Disorder: Investigating Long-Term EffectivenessLamotrigine And Borderline Personality Disorder: Investigating Long-Term Effectiveness - LABILE Borderline Personality Disorder
MedDRA version: 14.1;Level: PT;Classification code 10042033;Term: Stevens-Johnson syndrome;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 14.1;Classification code 10019211;Term: Headache;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 15.0;Level: LLT;Classification code 10028821;Term: Nausea with vomiting;System Organ Class: 100000004856
MedDRA version: 14.1;Classification code 10040913;Term: Skin rash;Classification code 10024264;Term: Lethargy;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1;Classification code 10013649;Term: Drowsiness;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
Trade Name: Lamotrigine - generic product
Product Name: Lamotrigine
Product Code: n/a
INN or Proposed INN: Lamotrigine
Other descriptive name: 6-(2,3-dichlorophenyl)-1,2,4-triazine-3,5-diamine
Imperial College LondonNULLNot Recruiting Female: yes
Male: yes
252 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
9NCT01696500
(ClinicalTrials.gov)
October 201220/9/2012Phase III Clinical Trial of NPB-01 in Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.Stevens-Johnson Syndrome;Toxic Epidermal NecrolysisDrug: Intravenous immunoglobulinNihon Pharmaceutical Co., LtdNULLCompleted20 YearsN/ABoth10Phase 3Japan
10NCT01582880
(ClinicalTrials.gov)
March 201210/4/2012Use of Cross-linked Donor Corneas as Carriers for the Boston KeratoprosthesisThe Use of Riboflavin/Ultraviolet A Cross-linked Human Donor Corneas as Carriers for the Boston KeratoprosthesisChemical Injuries;Unspecified Complication of Corneal Transplant;Autoimmune Diseases;Ocular Cicatricial Pemphigoid;Stevens Johnson Syndrome;Lupus Erythematosus, Systemic;Rheumatoid Arthritis;Other Autoimmune DiseasesDrug: RiboflavinJoseph B. Ciolino, MDNULLCompleted18 YearsN/AAll1Phase 1/Phase 2United States
11NCT01256489
(ClinicalTrials.gov)
December 201019/11/2010Infliximab to Improve Retention of the Boston Keratoprosthesis in Patients After Stevens Johnson Syndrome/ Toxic Epidermal Necrolysis (SJS/TENS)Infliximab Therapy to Improve Retention of the Boston Keratoprosthesis in Patients After Stevens Johnson Syndrome/ Toxic Epidermal NecrolysisStevens-Johnson Syndrome;Corneal BlindnessDrug: InfliximabMassachusetts Eye and Ear InfirmaryNULLWithdrawn18 YearsN/ABoth0Phase 1/Phase 2United States
12NCT02037347
(ClinicalTrials.gov)
October 201013/1/2014Study to Evaluate the Use of Palifermin to Treat Toxic Epidermal NecrolysisPalifermin Treatment of Toxic Epidermal NecrolysisToxic Epidermal Necrolysis;Stevens-Johnson SyndromeDrug: PaliferminBrett KingSwedish Orphan BiovitrumTerminated18 YearsN/AAll1Phase 1/Phase 2United States
13NCT01488396
(ClinicalTrials.gov)
February 20078/11/2010Efficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Syndrome Patient With Chronic Dry EyeEfficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Syndrome Patient With Chronic Dry EyeStevens-Johnson SyndromeDrug: 0.05%cyclosporin eye dropMahidol UniversityNULLCompleted18 YearsN/ABoth31Phase 4Thailand