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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT02987257 (ClinicalTrials.gov) | March 15, 2022 | 25/11/2016 | NATIENS: Optimal Management and Mechanisms of SJS/TEN | NATIENS: A Phase III Randomized Double-Blinded Placebo Controlled Study to Determine the Optimal Management and Mechanisms of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis | Stevens-Johnson Syndrome;Toxic Epidermal Necrolyses | Drug: Harmonized supportive care;Drug: Cyclosporine 5 mg/kg bid days 0-14;Drug: Etanercept 50 mg sc day 0 and day 3 | Vanderbilt University Medical Center | University of Ottawa;University of Toronto | Not yet recruiting | 18 Years | N/A | All | 267 | Phase 3 | United States |
| 2 | JPRN-jRCTs031210325 | 01/10/2021 | 17/09/2021 | Etanercept therapy for Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) cases of refractory to systemic steroid therapy | open-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 Riichirou | NULL | Recruiting | >= 20age old | Not applicable | Both | 10 | Phase 2 | Japan |
| 3 | EUCTR2020-003544-83-FR (EUCTR) | 16/03/2021 | 08/01/2021 | Evaluation de l’efficacité thérapeutique du filgrastim dans les allergies sévères bulleuses aux médicaments s’exprimant sous forme de Lyell et Stevens-Johnson Etude GNET | Evaluation 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 Clinique | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 2;Phase 3 | France | ||
| 4 | NCT03585946 (ClinicalTrials.gov) | January 1, 2021 | 14/3/2018 | Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis | A Prospective Multicenter Cohort Study Assessing Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis | Stevens-Johnson Syndrome;Toxic Epidermal Necrolysis;Drug Reaction | Drug: Site specific standard of care comparison | Massachusetts General Hospital | NULL | Not yet recruiting | 18 Years | N/A | All | 750 | NULL | |
| 5 | JPRN-jRCTs061180044 | 01/06/2017 | 12/03/2019 | Multicenter Open-trial of Steroid pulse therapy for SJS/TEN | Multicenter Open-trial of Steroid pulse therapy for SJS/TEN - MOSST Study | Stevens-Johnson syndrome and Toxic epidermal necrolysis | 1. 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 Eishin | NULL | Complete | >= 20age old | <= 90age old | Both | 20 | Phase 2 | Taiwan;Germany;Japan |
| 6 | NCT02126020 (ClinicalTrials.gov) | November 2014 | 27/4/2014 | Topical Infliximab in Autoimmune Eyes With Keratoprosthesis | Topical Infliximab in Autoimmune Eyes With Keratoprosthesis | Stevens-Johnson Syndrome;Toxic Epidermal Necrolysis (Lyell) Syndrome;Mucous Membrane Pemphigoid | Drug: topical infliximab | James Chodosh, MD, MPH | Massachusetts Eye and Ear Infirmary;Fonds de recherche en ophtalmologie de l'Université de Montréal (FROUM) | Withdrawn | 18 Years | 80 Years | All | 0 | Phase 1/Phase 2 | United States;Canada |
| 7 | NCT02149732 (ClinicalTrials.gov) | May 2014 | 14/5/2014 | Clinical Trial on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation | An Investigator-initiated Trial (IIT) on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation in Corneal Limbal Deficiency Patients | Limbal Stem Cell Deficiency;Stevens-johnson Syndrome;Ocular Cicatricial Pemphigoid;Chemical Burn | Biological: cultivated oral mucosal epithelial sheet transplantation | Seoul National University Hospital | Ministry of Health & Welfare, Korea | Available | 16 Years | N/A | Both | Phase 1/Phase 2 | Korea, Republic of | |
| 8 | EUCTR2012-003136-23-GB (EUCTR) | 27/11/2012 | 16/11/2012 | Lamotrigine And Borderline Personality Disorder: Investigating Long-Term Effectiveness | Lamotrigine 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 London | NULL | Not 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): yes | United Kingdom | ||
| 9 | NCT01696500 (ClinicalTrials.gov) | October 2012 | 20/9/2012 | Phase 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 Necrolysis | Drug: Intravenous immunoglobulin | Nihon Pharmaceutical Co., Ltd | NULL | Completed | 20 Years | N/A | Both | 10 | Phase 3 | Japan |
| 10 | NCT01582880 (ClinicalTrials.gov) | March 2012 | 10/4/2012 | Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis | The Use of Riboflavin/Ultraviolet A Cross-linked Human Donor Corneas as Carriers for the Boston Keratoprosthesis | Chemical Injuries;Unspecified Complication of Corneal Transplant;Autoimmune Diseases;Ocular Cicatricial Pemphigoid;Stevens Johnson Syndrome;Lupus Erythematosus, Systemic;Rheumatoid Arthritis;Other Autoimmune Diseases | Drug: Riboflavin | Joseph B. Ciolino, MD | NULL | Completed | 18 Years | N/A | All | 1 | Phase 1/Phase 2 | United States |
| 11 | NCT01256489 (ClinicalTrials.gov) | December 2010 | 19/11/2010 | Infliximab 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 Necrolysis | Stevens-Johnson Syndrome;Corneal Blindness | Drug: Infliximab | Massachusetts Eye and Ear Infirmary | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 1/Phase 2 | United States |
| 12 | NCT02037347 (ClinicalTrials.gov) | October 2010 | 13/1/2014 | Study to Evaluate the Use of Palifermin to Treat Toxic Epidermal Necrolysis | Palifermin Treatment of Toxic Epidermal Necrolysis | Toxic Epidermal Necrolysis;Stevens-Johnson Syndrome | Drug: Palifermin | Brett King | Swedish Orphan Biovitrum | Terminated | 18 Years | N/A | All | 1 | Phase 1/Phase 2 | United States |
| 13 | NCT01488396 (ClinicalTrials.gov) | February 2007 | 8/11/2010 | Efficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Syndrome Patient With Chronic Dry Eye | Efficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Syndrome Patient With Chronic Dry Eye | Stevens-Johnson Syndrome | Drug: 0.05%cyclosporin eye drop | Mahidol University | NULL | Completed | 18 Years | N/A | Both | 31 | Phase 4 | Thailand |