35. 天疱瘡 Pemphigus Clinical trials / Disease details
臨床試験数 : 99 / 薬物数 : 124 - (DrugBank : 36) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 169
| 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 | NCT02613910 (ClinicalTrials.gov) | December 23, 2015 | 23/11/2015 | Long-Term Extension Study of Ofatumumab in Subjects With Pemphigus Vulgaris | OPV117059: A Long-Term Extension Study of Ofatumumab Injection for Subcutaneous Use in Subjects With Pemphigus Vulgaris | Pemphigus | Drug: Ofatumumab;Drug: Acetaminophen/paracetamol;Drug: Antihistamine (cetirizine or equivalent);Drug: Prednisone/Prednisolone | GlaxoSmithKline | NULL | Terminated | N/A | N/A | All | 1 | Phase 3 | United States |
| 2 | EUCTR2013-001370-20-PL (EUCTR) | 03/07/2015 | 23/04/2015 | Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris | OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris | Pemphigus Vulgaris MedDRA version: 19.1;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | Glaxo Group Ltd | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of | ||
| 3 | EUCTR2013-001370-20-FR (EUCTR) | 20/04/2015 | 13/07/2015 | Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris | OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris | Pemphigus Vulgaris MedDRA version: 18.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | Glaxo Group Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 136 | United States;France;Poland;Ukraine;Croatia;Australia;Russian Federation;Israel;Italy;Japan;China;Korea, Republic of | |||
| 4 | EUCTR2013-001370-20-GR (EUCTR) | 12/12/2014 | 11/12/2014 | Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris | OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris | Pemphigus Vulgaris MedDRA version: 17.1;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | Glaxo Group Ltd | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of | ||
| 5 | EUCTR2013-001370-20-IT (EUCTR) | 26/11/2014 | 25/08/2014 | Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris | OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris | Pemphigus Vulgaris MedDRA version: 17.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | Glaxo Group Ltd | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of | ||
| 6 | EUCTR2013-001370-20-HR (EUCTR) | 17/11/2014 | 02/12/2014 | Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris | OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris | Pemphigus Vulgaris MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of | ||
| 7 | NCT01920477 (ClinicalTrials.gov) | August 13, 2013 | 3/7/2013 | Efficacy and Safety of Ofatumumab in Treatment of Pemphigus Vulgaris | OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects With Pemphigus Vulgaris | Pemphigus Vulgaris | Biological: Ofatumumab;Biological: Placebo | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 70 Years | All | 35 | Phase 3 | United States;Australia;Greece;Israel;Italy;Japan;Poland;Romania;Croatia;France;Korea, Republic of;Russian Federation;Ukraine |