158. 結節性硬化症 Tuberous sclerosis Clinical trials / Disease details


臨床試験数 : 112 薬物数 : 71 - (DrugBank : 19) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 118

  
3 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-000752-34-SK
(EUCTR)
15/11/201901/10/2019Study to evaluate if the study medication, Rapamycin, topical cream, is effective and safe at treating facial angiofibroma in patients 6 years of age and over.A Phase 2/3, multi-center, double-blind, placebo-controlled, randomized, parallel-group, dose-response comparison of the efficacy and safety of a topical rapamycin cream for the treatment of facial angiofibromas (FA) associated with Tuberous Sclerosis Complex (TSC) in patients 6 years of age and over - Dose-ranging efficacy and safety study of topical rapamycin cream Facial Angiofibromas Associated with Tuberous Sclerosis Complex
MedDRA version: 20.0;Level: PT;Classification code 10002429;Term: Angiofibroma;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0;Classification code 10073678;Term: Juvenile angiofibroma;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps);Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Rapamycin cream, topical, 0.5%, 1.0% w/w
Product Code: Not applicable
INN or Proposed INN: SIROLIMUS
Product Name: Rapamycin cream, topical, 0.5%, 1.0% w/w
Product Code: Not applicable
INN or Proposed INN: SIROLIMUS
DSLPNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2;Phase 3United States;Czech Republic;Hungary;Slovakia;Spain;Australia;United Kingdom;New Zealand
2EUCTR2019-000752-34-HU
(EUCTR)
14/11/201918/11/2019 Study to evaluate if the study medication, Rapamycin, topical cream, is effective and safe at treating facial angiofibroma in patients 6 years of age and over.A Phase 2/3, multi-center, double-blind, placebo-controlled, randomized, parallel-group, dose-response comparison of the efficacy and safety of a topical rapamycin cream for the treatment of facial angiofibromas (FA) associated with Tuberous Sclerosis Complex (TSC) in patients 6 years of age and over - Dose-ranging efficacy and safety study of topical rapamycin cream Facial Angiofibromas Associated with Tuberous Sclerosis Complex
MedDRA version: 20.0;Level: PT;Classification code 10002429;Term: Angiofibroma;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0;Classification code 10073678;Term: Juvenile angiofibroma;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Rapamycin cream, topical, 0.5%, 1.0% w/w
Product Code: Not applicable
INN or Proposed INN: SIROLIMUS
DSLPNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Hungary;Slovakia;Spain;Australia;New Zealand;United Kingdom
3EUCTR2019-000752-34-CZ
(EUCTR)
02/06/2020Study to evaluate if the study medication, Rapamycin, topical cream, is effective and safe at treating facial angiofibroma in patients 6 years of age and over.A Phase 2/3, multi-center, double-blind, placebo-controlled, randomized, parallel-group, dose-response comparison of the efficacy and safety of a topical rapamycin cream for the treatment of facial angiofibromas (FA) associated with Tuberous Sclerosis Complex (TSC) in patients 6 years of age and over - Dose-ranging efficacy and safety study of topical rapamycin cream Facial Angiofibromas Associated with Tuberous Sclerosis Complex
MedDRA version: 20.0;Level: PT;Classification code 10002429;Term: Angiofibroma;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0;Classification code 10073678;Term: Juvenile angiofibroma;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps);Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Rapamycin cream, topical, 0.5%, 1.0% w/w
Product Code: Not applicable
INN or Proposed INN: SIROLIMUS
Product Name: Rapamycin cream, topical, 0.5%, 1.0% w/w
Product Code: Not applicable
INN or Proposed INN: SIROLIMUS
Dermatology Specialities Limited Partnership (DSLP)NULLNAFemale: yes
Male: yes
120Phase 2;Phase 3United States;Serbia;Hungary;Czech Republic;Slovakia;Spain;Australia;New Zealand