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
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2018-000338-36-IT (EUCTR) | 12/05/2021 | 04/06/2021 | Open-label, Long-term, Extension Treatment using Intra-Erythrocyte Dexamethasone Sodium Phosphate in Patients with Ataxia Telangiectasia Who Participated in the IEDAT-02-2015 Study. | Open-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 | 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 (soluzione 25mg/ml) Product Code: [Dexamethasone sodium phosphate] INN or Proposed INN: DEXAMETHASONE SODIUM PHOSPHATE | ERYDEL S.P.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 155 | Phase 3 | United States;Spain;Poland;Belgium;Australia;Norway;Germany;Tunisia;United Kingdom;Italy;India | ||
| 2 | EUCTR2018-000338-36-NO (EUCTR) | 06/11/2020 | 04/02/2020 | Not Applicable | Open-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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 155 | Phase 3 | United States;Spain;Poland;Belgium;Australia;Tunisia;Germany;Norway;United Kingdom;Italy;India | ||
| 3 | EUCTR2018-000338-36-GB (EUCTR) | 27/05/2020 | 20/01/2020 | Not Applicable | Open-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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 51 | Phase 3 | United States;Spain;Poland;Belgium;Australia;Israel;Norway;Germany;United Kingdom;India | ||
| 4 | EUCTR2018-000338-36-DE (EUCTR) | 20/09/2018 | 21/06/2018 | Not Applicable | Open-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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Poland;Belgium;Australia;Israel;Norway;Germany;United Kingdom;India | ||
| 5 | EUCTR2018-000338-36-BE (EUCTR) | 23/08/2018 | 28/06/2018 | Not Applicable | Open-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. | NULL | Authorised-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): no | United States;Poland;Spain;Belgium;Australia;Israel;Germany;India | ||
| 6 | EUCTR2018-000338-36-ES (EUCTR) | 31/05/2018 | 05/04/2018 | Not Applicable | Open-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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 61 | Phase 3 | United States;Poland;Belgium;Spain;Australia;Israel;Norway;Germany;Italy;United Kingdom;India | ||
| 7 | NCT02770807 (ClinicalTrials.gov) | March 2, 2017 | 2/5/2016 | EDS in Ataxia Telangiectasia Patients | 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 | Nervous System Disease;Genetic Syndrome | Drug: EDS-EP dose range of ~5-10 mg DSP/infusion;Drug: EDS-EP dose range of ~14-22 mg DSP/infusion;Drug: Placebo | Erydel | NULL | Completed | 6 Years | N/A | All | 175 | Phase 3 | United States;Australia;Belgium;Germany;India;Israel;Italy;Norway;Poland;Spain;Tunisia;United Kingdom |
| 8 | EUCTR2015-005241-31-NO (EUCTR) | 21/11/2016 | 02/06/2016 | n/a | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 175 | Phase 3 | United States;Spain;Poland;Belgium;Australia;Israel;Tunisia;Germany;Norway;United Kingdom;Italy;India | ||
| 9 | EUCTR2015-005241-31-IT (EUCTR) | 02/11/2016 | 28/02/2018 | n/a | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Tunisia;United States;Costa Rica;Spain;Turkey;Israel;Italy;United Kingdom;Belgium;Poland;Australia;Germany;Norway | ||
| 10 | EUCTR2015-005241-31-BE (EUCTR) | 21/10/2016 | 01/06/2016 | n/a | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Spain;Poland;Belgium;Australia;Israel;Tunisia;Germany;United Kingdom;Italy;India;Norway | ||
| 11 | EUCTR2015-005241-31-DE (EUCTR) | 14/09/2016 | 27/05/2016 | n/a | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 175 | Phase 3 | United States;Spain;Poland;Belgium;Australia;Israel;Tunisia;Norway;Germany;United Kingdom;Italy;India | ||
| 12 | EUCTR2015-005241-31-ES (EUCTR) | 31/05/2016 | 09/06/2016 | n/a | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Spain;Costa Rica;Turkey;Israel;United Kingdom;Italy;Belgium;Poland;Australia;Tunisia;Germany;Norway | ||
| 13 | EUCTR2005-003201-81-DE (EUCTR) | 20/12/2006 | 19/01/2007 | GACHE: German trial of Acyclovir and Corticosteroids in Herpes-simplex-virus-Encephalitis. A multicenter, multinational, randomized, double-blind, placebo-controlled German, Austrian and Dutch trial. - GACHE | GACHE: German trial of Acyclovir and Corticosteroids in Herpes-simplex-virus-Encephalitis. A multicenter, multinational, randomized, double-blind, placebo-controlled German, Austrian and Dutch trial. - GACHE | Herpes simplex virus type-1 (HSV-1) is the most frequent cause of fatal sporadic encephalitis in humans. Herpes simplex encephalitis (HSE) was one of the first viral infections to be successfully treated with antiviral drugs. Mortality has been significantly reduced since the introduction of acyclovir, a specific inhibitor of HSV replication. Despite appropriate and promptly initiated antiviral therapy the incidence of persistent neurological deficits remain unacceptably high. | Trade Name: Fortecortin Inject 40 mg Amp. Product Name: Fortecortin INN or Proposed INN: dexamethasone 21-dihydrogen phosphate | Universitätsklinikum Heidelberg | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Germany | ||
| 14 | NCT00187057 (ClinicalTrials.gov) | September 2002 | 12/9/2005 | Study for Treatment of Cancer in Children With Ataxia-telangiectasia | Pilot Study I for Treatment of Cancer in Children With Ataxia-Telangiectasia | Ataxia-Telangiectasia | Drug: vinblastine, vincristine, prednisone, daunorubicin;Drug: doxorubicin, methotrexate, cyclophosphamide, L-asparaginase;Drug: etoposide, cytarabine, mercaptopurine;Drug: dexamethasone, procarbazine;Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy | St. Jude Children's Research Hospital | Children's Hospital of Philadelphia;National Cancer Institute (NCI) | Completed | N/A | 10 Years | Both | 6 | N/A | United States |
| 15 | EUCTR2015-005241-31-PL (EUCTR) | 01/07/2016 | n/a | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Costa Rica;Spain;Turkey;Israel;Italy;United Kingdom;India;Poland;Belgium;Australia;Germany;Norway;Tunisia | |||
| 16 | EUCTR2018-000338-36-PL (EUCTR) | 06/11/2018 | Not Applicable | Open-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. | NULL | NA | Female: yes Male: yes | 155 | Phase 3 | United States;Spain;Belgium;Poland;Australia;Tunisia;Norway;Germany;United Kingdom;Italy;India |