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

  
17 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-005679-96-LT
(EUCTR)
06/03/201709/02/2017An Investigation into the Long-term Safety of Zorblisa (SD-101-6.0) cream used by Patients with Epidermolysis Bullosa.An Open Label, Multi-center, Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients with Epidermolysis Bullosa - Study to Evaluate the Long-term Safety of Zorblisa in Patients with Epidermolysis Bullosa Epidermolysis Bullosa
MedDRA version: 20.0;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: Zorblisa
Product Code: SD-101
INN or Proposed INN: ALLANTOIN
Other descriptive name: ALLANTOIN
Scioderm, INC, An Amicus Therapeutics CompanyNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;United States;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Netherlands
2EUCTR2014-002288-14-LT
(EUCTR)
07/12/201608/11/2016An Investigation into the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis BullosaA Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa - Study of Effectiveness and Safety of SD-101 in Subjects with Epidermolysis Bullosa/ ESSENCE Study Epidermolysis Bullosa
MedDRA version: 20.0;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: Zorblisa
Product Code: SD-101
INN or Proposed INN: ALLANTOIN
Other descriptive name: ALLANTOIN
Scioderm, An Amicus Therapeutics CompanyNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Serbia;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Belgium;Poland;Romania;Australia;Germany;Netherlands
3EUCTR2014-005679-96-ES
(EUCTR)
14/11/201609/09/2016An Investigation into the Long-term Safety of Zorblisa (SD-101-6.0) cream used by Patients with Epidermolysis Bullosa.An Open Label, Multi-center, Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients with Epidermolysis Bullosa - Study to Evaluate the Long-term Safety of Zorblisa in Patients with Epidermolysis Bullosa Epidermolysis Bullosa
MedDRA version: 19.0;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: Zorblisa
Product Code: SD-101
INN or Proposed INN: ALLANTOIN
Other descriptive name: ALLANTOIN
Scioderm, INCNULLNot RecruitingFemale: yes
Male: yes
130Phase 3France;United States;Poland;Spain;Lithuania;Austria;Netherlands;Germany;Italy;United Kingdom
4EUCTR2014-002288-14-ES
(EUCTR)
19/09/201605/08/2016An Investigation into the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis BullosaA Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa - Study of Effectiveness and Safety of SD-101 in Subjects with Epidermolysis Bullosa Epidermolysis Bullosa
MedDRA version: 19.0;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: Zorblisa
Product Code: SD-101
INN or Proposed INN: ALLANTOIN
Other descriptive name: ALLANTOIN
Scioderm, INC.NULLNot RecruitingFemale: yes
Male: yes
90Phase 3France;United States;Belgium;Poland;Spain;Lithuania;Austria;Germany;Netherlands;Italy;United Kingdom
5EUCTR2014-005679-96-NL
(EUCTR)
07/09/201502/03/2015An Investigation into the Long-term Safety of Zorblisa (SD-101-6.0) cream used by Patients with Epidermolysis Bullosa.An Open Label, Multi-center, Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients with Epidermolysis Bullosa - Study to Evaluate the Long-term Safety of Zorblisa in Patients with Epidermolysis Bullosa Epidermolysis Bullosa
MedDRA version: 18.1;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: Zorblisa
Product Code: SD-101
INN or Proposed INN: ALLANTOIN
Other descriptive name: ALLANTOIN
Scioderm, INCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130France;United States;Poland;Spain;Austria;Australia;Germany;Netherlands;Italy;United Kingdom
6EUCTR2014-002288-14-PL
(EUCTR)
10/08/201511/06/2015An Investigation into the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis BullosaA Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa - Study of Effectiveness and Safety of SD-101 in Subjects with Epidermolysis Bullosa/ESSENCE Study Epidermolysis Bullosa
MedDRA version: 20.0;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: Zorblisa
Product Code: SD-101
INN or Proposed INN: ALLANTOIN
Other descriptive name: ALLANTOIN
Scioderm, An Amicus Therapeutics CompanyNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;United States;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Belgium;Poland;Romania;Australia;Germany;Netherlands
7EUCTR2014-005679-96-DE
(EUCTR)
22/05/201511/03/2015An Investigation into the Long-term Safety of Zorblisa (SD-101-6.0) cream used by Patients with Epidermolysis Bullosa.An Open Label, Multi-center, Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients with Epidermolysis Bullosa - Study to Evaluate the Long-term Safety of Zorblisa in Patients with Epidermolysis Bullosa Epidermolysis Bullosa
MedDRA version: 20.0;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: Zorblisa
Product Code: SD-101
INN or Proposed INN: ALLANTOIN
Other descriptive name: ALLANTOIN
Scioderm, INC, An Amicus Therapeutics CompanyNULLNot Recruiting Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Netherlands
8EUCTR2014-005679-96-GB
(EUCTR)
22/04/201504/03/2015An Investigation into the Long-term Safety of Zorblisa (SD-101-6.0) cream used by Patients with Epidermolysis Bullosa.An Open Label, Multi-center, Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients with Epidermolysis Bullosa - Study to Evaluate the Long-term Safety of Zorblisa in Patients with Epidermolysis Bullosa Epidermolysis Bullosa
MedDRA version: 18.1;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: Zorblisa
Product Code: SD-101
INN or Proposed INN: ALLANTOIN
Other descriptive name: ALLANTOIN
Scioderm, INCNULLNot RecruitingFemale: yes
Male: yes
130Phase 3France;United States;Poland;Spain;Lithuania;Austria;Australia;Netherlands;Germany;Italy;United Kingdom
9EUCTR2014-002288-14-DE
(EUCTR)
31/03/201519/12/2014An Investigation into the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis BullosaA Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa - Study of Effectiveness and Safety of SD-101 in Subjects with Epidermolysis Bullosa/ESSENCE Study Epidermolysis Bullosa
MedDRA version: 20.0;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: Zorblisa
Product Code: SD-101
INN or Proposed INN: ALLANTOIN
Other descriptive name: ALLANTOIN
Scioderm, An Amicus Therapeutics CompanyNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;United States;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Belgium;Poland;Romania;Australia;Germany;Netherlands
10EUCTR2014-005679-96-AT
(EUCTR)
16/03/201512/02/2015An Investigation into the Long-term Safety of Zorblisa (SD-101-6.0) cream used by Patients with Epidermolysis Bullosa.An Open Label, Multi-center, Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients with Epidermolysis Bullosa - Study to Evaluate the Long-term Safety of Zorblisa in Patients with Epidermolysis Bullosa Epidermolysis Bullosa
MedDRA version: 20.0;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: Zorblisa
Product Code: SD-101
INN or Proposed INN: ALLANTOIN
Other descriptive name: ALLANTOIN
Scioderm, INCNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;United States;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Netherlands
11EUCTR2014-002288-14-NL
(EUCTR)
23/12/201403/07/2014An Investigation into the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis BullosaA Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa - Study of Effectiveness and Safety of SD-101 in Subjects with Epidermolysis Bullosa/ESSENCE Study Epidermolysis Bullosa
MedDRA version: 19.1;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: Zorblisa
Product Code: SD-101
INN or Proposed INN: ALLANTOIN
Other descriptive name: ALLANTOIN
Scioderm, An Amicus Therapeutics CompanyNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;United States;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Belgium;Poland;Romania;Australia;Netherlands;Germany
12EUCTR2014-002288-14-IT
(EUCTR)
18/12/201415/07/2014An Investigation into the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis BullosaA Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa - Study of Effectiveness and Safety of SD-101 in Subjects with Epidermolysis Bullosa Epidermolysis Bullosa
MedDRA version: 17.0;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: Zorblisa
Product Code: SD-101
INN or Proposed INN: ALLANTOIN
Other descriptive name: ALLANTOIN
Scioderm, INC.NULLNot RecruitingFemale: yes
Male: yes
90Phase 3France;United States;Belgium;Spain;Poland;Lithuania;Austria;Germany;Netherlands;United Kingdom;Italy
13EUCTR2014-002288-14-GB
(EUCTR)
26/09/201411/07/2014An Investigation into the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis BullosaA Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa - Study of Effectiveness and Safety of SD-101 in Subjects with Epidermolysis Bullosa/ESSENCE Study Epidermolysis Bullosa
MedDRA version: 19.1;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: Zorblisa
Product Code: SD-101
INN or Proposed INN: ALLANTOIN
Other descriptive name: ALLANTOIN
Scioderm, An Amicus Therapeutics CompanyNULLNot Recruiting Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Serbia;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Belgium;Poland;Romania;Australia;Germany;Netherlands
14EUCTR2014-002288-14-AT
(EUCTR)
08/08/201402/07/2014An Investigation into the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis BullosaA Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa - Study of Effectiveness and Safety of SD-101 in Subjects with Epidermolysis Bullosa/ESSENCE Study Epidermolysis Bullosa
MedDRA version: 19.0;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: Zorblisa
Product Code: SD-101
INN or Proposed INN: ALLANTOIN
Other descriptive name: ALLANTOIN
Scioderm, An Amicus Therapeutics CompanyNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;United States;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Netherlands
15EUCTR2014-002288-14-BE
(EUCTR)
14/12/2016An Investigation into the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis BullosaA Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa - Study of Effectiveness and Safety of SD-101 in Subjects with Epidermolysis Bullosa/ ESSENCE Study Epidermolysis Bullosa
MedDRA version: 19.0;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: Zorblisa
Product Code: SD-101
INN or Proposed INN: ALLANTOIN
Other descriptive name: ALLANTOIN
Scioderm INC, An Amicus Therapeutics CompanyNULLNAFemale: yes
Male: yes
150Phase 3Serbia;United States;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Netherlands
16EUCTR2014-005679-96-PL
(EUCTR)
11/12/2015An Investigation into the Long-term Safety of Zorblisa (SD-101-6.0) cream used by Patients with Epidermolysis Bullosa.An Open Label, Multi-center, Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients with Epidermolysis Bullosa - Study to Evaluate the Long-term Safety of Zorblisa in Patients with Epidermolysis Bullosa Epidermolysis Bullosa
MedDRA version: 20.0;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: Zorblisa
Product Code: SD-101
INN or Proposed INN: ALLANTOIN
Other descriptive name: ALLANTOIN
Scioderm, INC, An Amicus Therapeutics CompanyNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;United States;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Poland;Romania;Australia;Bulgaria;Germany;Netherlands
17EUCTR2014-005679-96-IT
(EUCTR)
21/01/2021An Investigation into the Long-term Safety of Zorblisa (SD-101-6.0) creamused by Patients with Epidermolysis Bullosa.An Open Label Multi-Center Extension Study to Evaluate the Long-term Safety of ZorblisaTM (SD-101-6.0) in Patients with Epidermolysis Bullosa - Long-term Safety study of Zorblisa in Patients with Epidermolysis Bullosa Epidermolysis Bullosa
MedDRA version: 20.0;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]
INN or Proposed INN: ALLANTOINASCIODERM, INCNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Israel;Serbia;United States;Spain;Lithuania;Austria;Netherlands;Germany;Bulgaria;Australia;Romania;Poland;Belgium;France;Italy;United Kingdom