Human fibroblast-derived dermal substitute, Dermagraft ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
36表皮水疱症4

36. 表皮水疱症


臨床試験数 : 163 薬物数 : 185 - (DrugBank : 46) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 125
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2012-001815-21-PT
(EUCTR)
07/06/201328/03/2013A 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.NULLNot RecruitingFemale: yes
Male: yes
26France;United States;Portugal;Canada;Spain;Poland;Austria;Germany
2EUCTR2012-001815-21-DE
(EUCTR)
22/05/201301/11/2012A 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.NULLNot RecruitingFemale: yes
Male: yes
26Portugal;United States;Spain;Austria;Australia;Germany
3EUCTR2012-001815-21-AT
(EUCTR)
24/01/201325/01/2013A 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.NULLNot RecruitingFemale: yes
Male: yes
26United States;Portugal;France;Canada;Spain;Poland;Austria;Germany
4EUCTR2012-001815-21-ES
(EUCTR)
18/01/201326/09/2012A 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.NULLNot RecruitingFemale: yes
Male: yes
25Portugal;United States;Spain;Austria;Australia;Germany