65. 原発性免疫不全症候群 Primary immunodeficiency Clinical trials / Disease details


臨床試験数 : 500 薬物数 : 614 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 217

  
12 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-000338-36-NO
(EUCTR)
06/11/202004/02/2020Not ApplicableOpen-label, Long-term, Extension Treatment using Intra-Erythrocyte Dexamethasone Sodium Phosphate in Patients with Ataxia Telangiectasia Who Participated in the IEDAT-02-2015 Study - OLE-IEDAT Patient with neurological symptoms of Ataxia Telangiectasia
MedDRA version: 21.0;Level: PT;Classification code 10003594;Term: Ataxia telangiectasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexamethasone sodium phosphate
INN or Proposed INN: Dexamethasone sodium phosphate
Other descriptive name: DEXAMETHASONE SODIUM PHOSPHATE PH. EUR.
EryDel S.p.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
155Phase 3United States;Spain;Poland;Belgium;Australia;Tunisia;Germany;Norway;United Kingdom;Italy;India
2EUCTR2018-000338-36-GB
(EUCTR)
27/05/202020/01/2020Not ApplicableOpen-label, Long-term, Extension Treatment using Intra-Erythrocyte Dexamethasone Sodium Phosphate in Patients with Ataxia Telangiectasia Who Participated in the IEDAT-02-2015 Study - OLE-IEDAT, version 5.0 Patient with neurological symptoms of Ataxia Telangiectasia
MedDRA version: 21.0;Level: PT;Classification code 10003594;Term: Ataxia telangiectasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexamethasone sodium phosphate
INN or Proposed INN: Dexamethasone sodium phosphate
Other descriptive name: DEXAMETHASONE SODIUM PHOSPHATE PH. EUR.
EryDel S.p.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
51Phase 3United States;Spain;Poland;Belgium;Australia;Israel;Norway;Germany;United Kingdom;India
3EUCTR2018-000338-36-DE
(EUCTR)
20/09/201821/06/2018Not ApplicableOpen-label, Long-term, Extension Treatment using Intra-Erythrocyte Dexamethasone Sodium Phosphate in Patients with Ataxia Telangiectasia Who Participated in the IEDAT-02-2015 Study - OLE-IEDAT Patient with neurological symptoms of Ataxia Telangiectasia
MedDRA version: 21.0;Level: PT;Classification code 10003594;Term: Ataxia telangiectasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexamethasone sodium phosphate
INN or Proposed INN: Dexamethasone sodium phosphate
Other descriptive name: DEXAMETHASONE SODIUM PHOSPHATE PH. EUR.
EryDel S.p.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Spain;Poland;Belgium;Australia;Israel;Norway;Germany;United Kingdom;India
4EUCTR2018-000338-36-BE
(EUCTR)
23/08/201828/06/2018Not ApplicableOpen-label, Long-term, Extension Treatment using Intra-Erythrocyte Dexamethasone Sodium Phosphate in Patients with Ataxia Telangiectasia Who Participated in the IEDAT-02-2015 Study - OLE-IEDAT Patient with neurological symptoms of Ataxia Telangiectasia
MedDRA version: 20.1;Level: PT;Classification code 10003594;Term: Ataxia telangiectasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexamethasone sodium phosphate
INN or Proposed INN: Dexamethasone sodium phosphate
Other descriptive name: DEXAMETHASONE SODIUM PHOSPHATE PH. EUR.
EryDel S.p.A.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
51 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Poland;Spain;Belgium;Australia;Israel;Germany;India
5EUCTR2018-000338-36-ES
(EUCTR)
31/05/201805/04/2018Not ApplicableOpen-label, Long-term, Extension Treatment using Intra-Erythrocyte Dexamethasone Sodium Phosphate in Patients with Ataxia Telangiectasia Who Participated in the IEDAT-02-2015 Study - OLE-IEDAT Patient with neurological symptoms of Ataxia Telangiectasia
MedDRA version: 20.1;Level: PT;Classification code 10003594;Term: Ataxia telangiectasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexamethasone sodium phosphate
INN or Proposed INN: Dexamethasone sodium phosphate
Other descriptive name: DEXAMETHASONE SODIUM PHOSPHATE PH. EUR.
EryDel S.p.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
61Phase 3United States;Poland;Belgium;Spain;Australia;Israel;Norway;Germany;Italy;United Kingdom;India
6EUCTR2015-005241-31-NO
(EUCTR)
21/11/201602/06/2016n/aA Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Effects of Intra-Erythrocyte Dexamethasone Sodium Phosphate on Neurological Symptoms in Patients with Ataxia Telangiectasia - Ataxia Telangiectasia - Treatment with EryDex SysTem - ATTEST Patient with neurological symptoms of Ataxia Telangiectasia
MedDRA version: 21.0;Level: PT;Classification code 10003594;Term: Ataxia telangiectasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexamethasone sodium phosphate
INN or Proposed INN: Dexamethasone sodium phosphate
Other descriptive name: DEXAMETHASONE SODIUM PHOSPHATE PH. EUR.
EryDel S.p.A.NULLNot RecruitingFemale: yes
Male: yes
175Phase 3United States;Spain;Poland;Belgium;Australia;Israel;Tunisia;Germany;Norway;United Kingdom;Italy;India
7EUCTR2015-005241-31-IT
(EUCTR)
02/11/201628/02/2018n/aA Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Effects of Intra-Erythrocyte Dexamethasone Sodium Phosphate on Neurological Symptoms in Patients with Ataxia Telangiectasia - EDS in Ataxia Telangiectasia Patients - IEDAT-02 Patient with neurological symptoms of Ataxia Telangiectasia
MedDRA version: 20.1;Level: PT;Classification code 10003594;Term: Ataxia telangiectasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexametasone Fosfato Sodico
INN or Proposed INN: Dexametasone Fosfato Sodico
Other descriptive name: DEXAMETHASONE SODIUM PHOSPHATE PH. EUR.
ERYDEL S.P.A.NULLNot RecruitingFemale: yes
Male: yes
180Phase 3Tunisia;United States;Costa Rica;Spain;Turkey;Israel;Italy;United Kingdom;Belgium;Poland;Australia;Germany;Norway
8EUCTR2015-005241-31-BE
(EUCTR)
21/10/201601/06/2016n/aA Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Effects of Intra-Erythrocyte Dexamethasone Sodium Phosphate on Neurological Symptoms in Patients with Ataxia Telangiectasia - Ataxia Telangiectasia - Treatment with EryDex SysTem - ATTEST Patient with neurological symptoms of Ataxia Telangiectasia
MedDRA version: 20.1;Level: PT;Classification code 10003594;Term: Ataxia telangiectasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexamethasone sodium phosphate
INN or Proposed INN: Dexamethasone sodium phosphate
Other descriptive name: DEXAMETHASONE SODIUM PHOSPHATE PH. EUR.
EryDel S.p.A.NULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Spain;Poland;Belgium;Australia;Israel;Tunisia;Germany;United Kingdom;Italy;India;Norway
9EUCTR2015-005241-31-DE
(EUCTR)
14/09/201627/05/2016n/aA Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Effects of Intra-Erythrocyte Dexamethasone Sodium Phosphate on Neurological Symptoms in Patients with Ataxia Telangiectasia - Ataxia Telangiectasia - Treatment with EryDex SysTem - ATTEST Patient with neurological symptoms of Ataxia Telangiectasia
MedDRA version: 21.0;Level: PT;Classification code 10003594;Term: Ataxia telangiectasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexamethasone sodium phosphate
INN or Proposed INN: Dexamethasone sodium phosphate
Other descriptive name: DEXAMETHASONE SODIUM PHOSPHATE PH. EUR.
EryDel S.p.A.NULLNot RecruitingFemale: yes
Male: yes
175Phase 3United States;Spain;Poland;Belgium;Australia;Israel;Tunisia;Norway;Germany;United Kingdom;Italy;India
10EUCTR2015-005241-31-ES
(EUCTR)
31/05/201609/06/2016n/aA Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Effects of Intra-Erythrocyte Dexamethasone Sodium Phosphate on Neurological Symptoms in Patients with Ataxia Telangiectasia - EDS in Ataxia Telangiectasia Patients - IEDAT-02 Patient with neurological symptoms of Ataxia Telangiectasia
MedDRA version: 19.0;Level: PT;Classification code 10003594;Term: Ataxia telangiectasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexamethasone sodium phosphate
INN or Proposed INN: Dexamethasone sodium phosphate
Other descriptive name: DEXAMETHASONE SODIUM PHOSPHATE PH. EUR.
EryDel S.p.A.NULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Spain;Costa Rica;Turkey;Israel;United Kingdom;Italy;Belgium;Poland;Australia;Tunisia;Germany;Norway
11EUCTR2015-005241-31-PL
(EUCTR)
01/07/2016n/aA Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Effects of Intra-Erythrocyte Dexamethasone Sodium Phosphate on Neurological Symptoms in Patients with Ataxia Telangiectasia - EDS in Ataxia Telangiectasia Patients - IEDAT-02 Patient with neurological symptoms of Ataxia Telangiectasia
MedDRA version: 21.0;Level: PT;Classification code 10003594;Term: Ataxia telangiectasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexamethasone sodium phosphate
INN or Proposed INN: Dexamethasone sodium phosphate
Other descriptive name: DEXAMETHASONE SODIUM PHOSPHATE PH. EUR.
EryDel S.p.A.NULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Costa Rica;Spain;Turkey;Israel;Italy;United Kingdom;India;Poland;Belgium;Australia;Germany;Norway;Tunisia
12EUCTR2018-000338-36-PL
(EUCTR)
06/11/2018Not ApplicableOpen-label, Long-term, Extension Treatment using Intra-Erythrocyte Dexamethasone Sodium Phosphate in Patients with Ataxia Telangiectasia Who Participated in the IEDAT-02-2015 Study - OLE-IEDAT Patient with neurological symptoms of Ataxia Telangiectasia
MedDRA version: 21.0;Level: PT;Classification code 10003594;Term: Ataxia telangiectasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexamethasone sodium phosphate
INN or Proposed INN: Dexamethasone sodium phosphate
Other descriptive name: DEXAMETHASONE SODIUM PHOSPHATE PH. EUR.
EryDel S.p.A.NULLNAFemale: yes
Male: yes
155Phase 3United States;Spain;Belgium;Poland;Australia;Tunisia;Norway;Germany;United Kingdom;Italy;India