Abh001    (DrugBank: ABH001)

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5

36. 表皮水疱症 [臨床試験数:147,薬物数:170(DrugBank:40),標的遺伝子数:32,標的パスウェイ数:113
Searched query = "Epidermolysis bullosa", "EBS", "JEB", "DDEB", "RDEB", "Kindler syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
5 / 147 trials found
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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
5NCT01749306
(ClinicalTrials.gov)
December 201211/12/2012A Study of the Efficacy and Safety of ABH001 in the Treatment of Patients With Epidermolysis Bullosa Who Have Wounds That Are Not HealingA 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 BullosaEpidermolysis BullosaBiological: ABH001;Other: Control wound treatmentShire Regenerative Medicine, Inc.NULLTerminatedN/AN/ABoth1Phase 3United States;Austria;Canada;France;Germany;Poland;Portugal;Spain