36. 表皮水疱症 Epidermolysis bullosa Clinical trials / Disease details
臨床試験数 : 160 / 薬物数 : 195 - (DrugBank : 47) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 124
| 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 | EUCTR2012-001815-21-PT (EUCTR) | 07/06/2013 | 28/03/2013 | A study of the safety and efficacy of ABH001 in the treatment of patients with epidermolysis bullosa who have wounds that are not healing. | A Multicenter, Prospective, Randomized, Open-label, Intra-patient Controlled Study of the Efficacy and Safety of ABH001 for the Treatment of Stalled Chronic Cutaneous Wounds Associated with Generalized Epidermolysis Bullosa | Epidermolysis bullosa MedDRA version: 14.1;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Human dermal fibroblasts cultured on a bioresorbable polyglactin mesh Product Code: ABH001 INN or Proposed INN: Human dermal fibroblasts cultured on a bioresorbable polyglactin mesh Other descriptive name: Human fibroblast-derived dermal substitute, Dermagraft | Shire Regenerative Medicine, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 26 | France;United States;Portugal;Canada;Spain;Poland;Austria;Germany | |||
| 2 | EUCTR2012-001815-21-DE (EUCTR) | 22/05/2013 | 01/11/2012 | A study of the safety and efficacy of ABH001 in the treatment of patients with epidermolysis bullosa who have wounds that are not healing. | A Multicenter, Prospective, Randomized, Open-label, Intra-patient Controlled Study of the Efficacy and Safety of ABH001 for the Treatment of Stalled Chronic Cutaneous Wounds Associated with Generalized Epidermolysis Bullosa | Epidermolysis bullosa MedDRA version: 14.1;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Human dermal fibroblasts cultured on a bioresorbable polyglactin mesh Product Code: ABH001 INN or Proposed INN: Human dermal fibroblasts cultured on a bioresorbable polyglactin mesh Other descriptive name: Human fibroblast-derived dermal substitute, Dermagraft | Shire Regenerative Medicine, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 26 | Portugal;United States;Spain;Austria;Australia;Germany | |||
| 3 | EUCTR2012-001815-21-AT (EUCTR) | 24/01/2013 | 25/01/2013 | A study of the safety and efficacy of ABH001 in the treatment of patients with epidermolysis bullosa who have wounds that are not healing. | A Multicenter, Prospective, Randomized, Open-label, Intra-patient Controlled Study of the Efficacy and Safety of ABH001 for the Treatment of Stalled Chronic Cutaneous Wounds Associated with Generalized Epidermolysis Bullosa | Epidermolysis bullosa MedDRA version: 16.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Human dermal fibroblasts cultured on a bioresorbable polyglactin mesh Product Code: ABH001 INN or Proposed INN: Human dermal fibroblasts cultured on a bioresorbable polyglactin mesh Other descriptive name: Human fibroblast-derived dermal substitute, Dermagraft | Shire Regenerative Medicine, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 26 | United States;Portugal;France;Canada;Spain;Poland;Austria;Germany | |||
| 4 | EUCTR2012-001815-21-ES (EUCTR) | 18/01/2013 | 26/09/2012 | A study of the safety and efficacy of ABH001 in the treatment of patients with epidermolysis bullosa who have wounds that are not healing. | A Multicenter, Prospective, Randomized, Open-label, Intra-patient Controlled Study of the Efficacy and Safety of ABH001 for the Treatment of Stalled Chronic Cutaneous Wounds Associated with Generalized Epidermolysis Bullosa | Epidermolysis bullosa MedDRA version: 15.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Human dermal fibroblasts cultured on a bioresorbable polyglactin mesh Product Code: ABH001 INN or Proposed INN: Human dermal fibroblasts cultured on a bioresorbable polyglactin mesh Other descriptive name: Human fibroblast-derived dermal substitute, Dermagraft | Shire Regenerative Medicine, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 25 | Portugal;United States;Spain;Austria;Australia;Germany | |||
| 5 | NCT01749306 (ClinicalTrials.gov) | December 2012 | 11/12/2012 | A Study of the Efficacy and Safety of ABH001 in the Treatment of Patients With Epidermolysis Bullosa Who Have Wounds That Are Not Healing | A Multicenter, Prospective, Randomized, Open-label, Intra-subject Controlled Study of the Efficacy and Safety of ABH001 for the Treatment of Stalled Chronic Cutaneous Wounds Associated With Generalized Epidermolysis Bullosa | Epidermolysis Bullosa | Biological: ABH001;Other: Control wound treatment | Shire Regenerative Medicine, Inc. | NULL | Terminated | N/A | N/A | Both | 1 | Phase 3 | United States;Austria;Canada;France;Germany;Poland;Portugal;Spain |