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 : 17 / 薬物数 : 29 - (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, 2023 | 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 | NCT05520086 (ClinicalTrials.gov) | November 11, 2022 | 22/8/2022 | Clinical Trial to Evaluate Safety and Efficacy of Cell Therapy in Patients With Cicatricial Conjuntivitis. | Phase IIa Multicenter Clinical Trial to Determine the Feasibility and Safety of the Use of Adipose-derived Mesenchymal Stem Cells (ASC) in the Treatment of Patients With Cicatricial Conjunctivitis Associated With Lyell's Syndrome, Stevens-Johnson Syndrome and Pemphigoid of the Mucous Membranes With Ocular Involvement. | Chronic Conjunctivitis;Stevens-Johnson Syndrome;Lyell Syndrome;Pemphigoid | Drug: Single Dose;Drug: Double Dose | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz | Effice Servicios Para la Investigacion S.L. | Recruiting | 18 Years | N/A | All | 20 | Phase 1/Phase 2 | Spain |
| 3 | EUCTR2021-005486-40-ES (EUCTR) | 22/07/2022 | 11/02/2022 | Clinical Trial to evaluate safety and efficacy of cell therapy in patients with cicatricial conjuntivitis | Phase IIa multicenter clinical trial to determine the feasibility and safety of the use of adipose-derived mesenchymal stem cells (ASC) in the treatment of patients with cicatricial conjunctivitis associated with Lyell's syndrome, Stevens-Johnson syndrome and pemphigoid of the mucous membranes with ocular involvement. | Cicatricial conjunctivitis associated with Lyell's syndrome, Stevens-Johnson syndrome and mucous membrane pemphigoid with ocular involvement.;Therapeutic area: Diseases [C] - Eye Diseases [C11] | Product Name: allogenic mesenchymal stem cell isolated from adipose tissue INN or Proposed INN: ALLOGENEIC ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS EXPANDED Other descriptive name: ALLOGENEIC ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS EXPANDED Product Name: allogenic mesenchymal stem cell isolated from adipose tissue INN or Proposed INN: ALLOGENEIC ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS EXPANDED Other descriptive name: ALLOGENEIC ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS EXPANDED | FUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Spain | ||
| 4 | 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 |
| 5 | 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 | ||
| 6 | 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 | |
| 7 | 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 |
| 8 | NCT05284929 (ClinicalTrials.gov) | May 17, 2017 | 10/3/2022 | Human Leukocyte Antigen Class II (DRB1 and DQB1) Alleles and Haplotypes Frequencies in Patients With Pemphigus Vulgaris Among the Russian Population | Increased Frequencies of Certain HLA Class II Alleles DRB1 and DQB1 in PV Patients Compared to Those in Healthy Donors Have Been Reported in Various Populations and Repeatedly Confirmed. Among the Russian Population, no Studies About the Association of PV and HLA Class II Genes Have Been Conducted. Thus, the Purpose of This Study Was to Investigate HLA Class II Alleles and Haplotypes in Russian Patients With Pemphigus Vulgaris. | Pemphigus;Bullous Pemphigoid;Stevens-Johnson Syndrome;Toxic Epidermal Necrolyses | Genetic: A single blood sample for HLA typing | Sechenov University | Pirogov Russian National Research Medical University | Recruiting | N/A | N/A | All | 120 | Russian Federation | |
| 9 | NCT03046914 (ClinicalTrials.gov) | February 24, 2016 | 6/2/2017 | HLA-B*5801 Screening to Prevent Allopurinol-induced Severe Cutaneous Adverse Reaction | A Prospective Study to Prove the Usefulness of HLA-B*5801 Screening Test for the Prevention of Allopurinol-induced Severe Cutaneous Adverse Reaction in Patient With Chronic Kidney Disease | Stevens-Johnson Syndrome;Kidney Failure, Chronic | Genetic: HLA-B*5801 test | Seoul National University Hospital | Ministry of Food and Drug Safety, Korea | Recruiting | N/A | N/A | All | 600 | N/A | Korea, Republic of |
| 10 | 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 |
| 11 | 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 | |
| 12 | 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 | ||
| 13 | 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 |
| 14 | 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 |
| 15 | 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 |
| 16 | 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 |
| 17 | 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 |