TETRACOSACTIDE ( DrugBank: Tetracosactide )


4 diseases
告示番号疾患名(ページ内リンク)臨床試験数
83アジソン病2
113筋ジストロフィー4
145ウエスト症候群2
222一次性ネフローゼ症候群1

83. アジソン病


臨床試験数 : 20 薬物数 : 39 - (DrugBank : 13) / 標的遺伝子数 : 6 - 標的パスウェイ数 : 18
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2012-001682-33-GB
(EUCTR)
06/09/201215/06/2012Rescue of Addison’s disease 2Combined Immunotherapy and Trophic Adrenocortical Stimulation in New Onset Autoimmune Addison’s Disease - Rescue of Addison’s disease 2 (RADS2) Autoimmune Addison's disease: autoimmune primary adrenal insufficiency
MedDRA version: 16.1;Level: PT;Classification code 10052381;Term: Primary adrenal insufficiency;System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 16.1;Level: LLT;Classification code 10001335;Term: Adrenal cortex insufficiency;Classification code 10001342;Term: Adrenal cortical hypofunction;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Mabthera infusion
Product Name: Mabthera Infusion
Product Code: Rituximab
Trade Name: Solu-Medrone
Product Name: Solu-Medrone
Product Code: Methylprednisolone
Trade Name: Synacthen Depot
Product Name: Synacthen Depot
Product Code: Tetracosactide acetate
Newcastle upon Tyne Hospitals NHS Foundation TrustNULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
2NCT01371526
(ClinicalTrials.gov)
September 20109/3/2011Revival of Stem Cells in Addison's StudyRevival of Autochthonous Adrenocortical Stem Cells in Autoimmune Addison's DiseaseAdrenal FailureDrug: depot tetracosactideNewcastle UniversityNULLCompleted16 Years66 YearsBoth13Phase 4United Kingdom

113. 筋ジストロフィー


臨床試験数 : 646 薬物数 : 471 - (DrugBank : 105) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 170
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-004139-35-IT
(EUCTR)
31/08/201817/06/2021Clinical Trial in Male Subjects with Muscular DiseaseA Multicenter, Randomized, Parallel Group, Double Blind, Multiple Dose, Placebo Controlled Study to Assess the Efficacy and Safety of MNK-1411 in Male Subjects 4 to 8 Years of Age With Duchenne Muscular Dystrophy - Clinical Trial in Male Subjects with Muscular Disease Duchenne Muscular Distrophy
MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cosintropina acetato
Product Code: [MNK-1411]
INN or Proposed INN: TETRACOSACTIDE ESACETATO
Other descriptive name: Cosyntropin acetate
Trade Name: Synacthen Ampoules 250 mcg
Product Name: Synacthen Ampoules 250 microgrammi
Product Code: [Synacthen Ampoules 250 microgrammi]
INN or Proposed INN: TETRACOSACTIDE
MALLINCKRODT ARD INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
132Phase 2Serbia;United States;Spain;Costa Rica;Ukraine;Ireland;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Puerto Rico;Poland;Bulgaria
2EUCTR2017-004139-35-BG
(EUCTR)
28/08/201828/06/2018Clinical Trial in Male Subjects with Muscular DiseaseA Multicenter, Randomized, Parallel Group, Double Blind, Multiple Dose, Placebo Controlled Study to Assess the Efficacy and Safety of MNK-1411 in Male Subjects 4 to 8 Years of Age With Duchenne Muscular Dystrophy Duchenne Muscular Distrophy
MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cosyntropin acetate
Product Code: MNK-1411
INN or Proposed INN: TETRACOSACTIDE HEXAACETATE
Other descriptive name: Cosyntropin acetate
Mallinckrodt ARD Inc.NULLNot Recruiting Female: no
Male: yes
132 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Spain;Turkey;Chile;Israel;United Kingdom;Italy;Canada;Argentina;Belgium;Bulgaria;Germany;Netherlands
3EUCTR2017-004139-35-BE
(EUCTR)
18/06/201803/04/2018Clinical Trial in Male Subjects with Muscular DiseaseA Multicenter, Randomized, Parallel Group, Double Blind, Multiple Dose, Placebo Controlled Study to Assess the Efficacy and Safety of MNK-1411 in Male Subjects 4 to 8 Years of Age With Duchenne Muscular Dystrophy Duchenne Muscular Distrophy
MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cosyntropin acetate
Product Code: MNK-1411
INN or Proposed INN: TETRACOSACTIDE HEXAACETATE
Other descriptive name: Cosyntropin acetate
Mallinckrodt ARD Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
132Phase 2United States;Serbia;Spain;Turkey;Chile;Israel;United Kingdom;Italy;Canada;Argentina;Belgium;Germany;Netherlands
4EUCTR2017-004139-35-ES
(EUCTR)
12/06/201819/03/2018Clinical Trial in Male Subjects with Muscular DiseaseA Multicenter, Randomized, Parallel Group, Double Blind, Multiple Dose, Placebo Controlled Study to Assess the Efficacy and Safety of MNK-1411 in Male Subjects 4 to 8 Years of Age With Duchenne Muscular Dystrophy Duchenne Muscular Distrophy
MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cosyntropin acetate
Product Code: MNK-1411
INN or Proposed INN: TETRACOSACTIDE HEXAACETATE
Other descriptive name: Cosyntropin acetate
Mallinckrodt ARD Inc.NULLNot Recruiting Female: no
Male: yes
132 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Serbia;Spain;Turkey;Chile;Israel;United Kingdom;Italy;Canada;Argentina;Belgium;Bulgaria;Germany;Netherlands

145. ウエスト症候群


臨床試験数 : 43 薬物数 : 52 - (DrugBank : 15) / 標的遺伝子数 : 28 - 標的パスウェイ数 : 26
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2006-000788-27-DE
(EUCTR)
23/09/201011/06/2010International Collaborative Study of a type of epilepsy called Infantile SpasmsInternational Collaborative Infantile Spasms Study (ICISS) - ICISS Infantile spasms are a rare severe form of epilepsy affecting approx 1 in 2,250 infants, usually under the age of 1 year. Affected infants have a very abnormal EEG and a poor prognosis for subsequent epilepsy and neuro-development. There is a high risk of underlying neurological disease that independently causes delayed development and other seizure disorders. There is a high risk of a poor outcome even when there is no other detectable underlying neurological disorder.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: SABRIL
INN or Proposed INN: Vigabatrin
Trade Name: Synacthen Depot
INN or Proposed INN: Tetracosactide Acetate
Trade Name: Decortin H
INN or Proposed INN: Prednisolone
Royal United Hospital Bath NHS TrustNULLNot RecruitingFemale: yes
Male: yes
410Phase 4Australia;Germany;United Kingdom;Switzerland;New Zealand
2EUCTR2006-000788-27-GB
(EUCTR)
20/04/200606/03/2006International Collaborative Infantile Spasms Study (ICISS) - ICISSInternational Collaborative Infantile Spasms Study (ICISS) - ICISS Infantile spasms are a rare severe form of epilepsy affecting approx 1 in 2,250 infants, usually under the age of 1 year. Affected infants have a very abnormal EEG and a poor prognosis for subsequent epilepsy and neuro-development. There is a high risk of underlying neurological disease that independently causes delayed development and other seizure disorders. There is a high risk of a poor outcome even when there is no other detectable underlying neurological disorder.Trade Name: SABRIL SACHETS
INN or Proposed INN: Vigabatrin
Trade Name: SYNACTHEN DEPOT
INN or Proposed INN: Tetracosactide Acetate
Trade Name: SOLUBLE PREDNISOLONE TABLETS
INN or Proposed INN: Prednisolone
Royal United Hospital Bath NHS TrustNULLNot RecruitingFemale: yes
Male: yes
410Phase 4Germany;United Kingdom

222. 一次性ネフローゼ症候群


臨床試験数 : 310 薬物数 : 295 - (DrugBank : 117) / 標的遺伝子数 : 63 - 標的パスウェイ数 : 194
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00694863
(ClinicalTrials.gov)
July 20089/6/2008Treatment With Synthetic ACTH in High Risk Patients With Membranous NephropathyTreatment With Synthetic Adrenocorticotropic Hormone (ACTH) in Patients With Membranous Nephropathy and High Risk for Renal Failure. A Pilot StudyIdiopathic Membranous NephropathyDrug: tetracosactide hexacetaatRadboud UniversityDutch Kidney FoundationCompleted18 Years95 YearsBoth20Phase 2Netherlands