Lenti-D Drug Product
( DrugBank: - / KEGG DRUG: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 20 | 副腎白質ジストロフィー | 12 |
20. 副腎白質ジストロフィー
臨床試験数 : 61 / 薬物数 : 90 - (DrugBank : 31) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 126
Showing 1 to 10 of 12 trials
| 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 | EUCTR2015-002805-13-NL (EUCTR) | 07/09/202120210907 | 30/04/202120210430 | Longterm Follow-up of Subjects With Cerebral Adrenoleukodystrophy Who Were Treated With Lenti-D Drug Product Longterm Follow-up of Subjects With Cerebral Adrenoleukodystrophy Who Were Treated With Lenti-D Drug ... | Longterm Follow-up of Subjects With Cerebral Adrenoleukodystrophy Who Were Treated With Lenti-D Drug Product Longterm Follow-up of Subjects With Cerebral Adrenoleukodystrophy Who Were Treated With Lenti-D Drug ... | Cerebral Adrenoleukodystrophy (CALD) MedDRA version: 20.0;Level: PT;Classification code 10051260;Term: Adrenoleukodystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] Cerebral Adrenoleukodystrophy (CALD) MedDRA version: 20.0;Level: PT;Classification code 10051260;Ter ... | Product Name: Lenti-D Drug Product INN or Proposed INN: Elivaldogene autotemcel Other descriptive name: AUTOLOGOUS CD34+ CELLS TRANSDUCED WITH LENTI-D VECTOR ENCODING ABCD1 CDNA ProductName: Lenti-D Drug Product INN or Proposed INN: Elivaldogene autotemcel Other descriptive name: ... | bluebird bio, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 60 | Phase 3 | France;United States;Argentina;Brazil;Australia;Netherlands;United Kingdom | ||
| 2 | EUCTR2018-001145-14-DE (EUCTR) | 23/01/202020200123 | 27/11/201820181127 | Clinical study to assess the efficacy and safety of gene therapy for the treatment of cerebral adrenoleukodystrophy (CALD) Clinical study to assess the efficacy and safety of gene therapy for the treatment of cerebral adren ... | A Phase 3 Study of Lenti-D Drug Product After Myeloablative Conditioning Using Busulfan and Fludarabine in Subjects =17 Years of Age With Cerebral Adrenoleukodystrophy (CALD) A Phase 3 Study of Lenti-D Drug ProductAfter Myeloablative Conditioning Using Busulfan and Fludarabi ... | Cerebral Adrenoleukodystrophy (CALD) MedDRA version: 20.0;Level: PT;Classification code 10051260;Term: Adrenoleukodystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] Cerebral Adrenoleukodystrophy (CALD) MedDRA version: 20.0;Level: PT;Classification code 10051260;Ter ... | Product Name: Lenti-D Drug Product INN or Proposed INN: elivaldogene autotemcel Other descriptive name: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA INN or Proposed INN: plerixafor Other descriptive name: PLERIXAFOR ProductName: Lenti-D Drug Product INN or Proposed INN: elivaldogene autotemcel Other descriptive name: ... | bluebird bio, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 35 | Phase 3 | France;United States;Netherlands;Germany;United Kingdom;Italy | ||
| 3 | EUCTR2018-001145-14-NL (EUCTR) | 24/06/201920190624 | 25/02/201920190225 | Clinical study to assess the efficacy and safety of gene therapy for the treatment of cerebral adrenoleukodystrophy (CALD) Clinical study to assess the efficacy and safety of gene therapy for the treatment of cerebral adren ... | A Phase 3 Study of Lenti-D Drug Product After Myeloablative Conditioning Using Busulfan and Fludarabine in Subjects =17 Years of Age With Cerebral Adrenoleukodystrophy (CALD) A Phase 3 Study of Lenti-D Drug ProductAfter Myeloablative Conditioning Using Busulfan and Fludarabi ... | Cerebral Adrenoleukodystrophy (CALD) MedDRA version: 20.0;Level: PT;Classification code 10051260;Term: Adrenoleukodystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] Cerebral Adrenoleukodystrophy (CALD) MedDRA version: 20.0;Level: PT;Classification code 10051260;Ter ... | Product Name: Lenti-D Drug Product Product Code: Not Applicable INN or Proposed INN: elivaldogene autotemcel Other descriptive name: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA ProductName: Lenti-D Drug Product ProductCode: Not Applicable INN or Proposed INN: elivaldogene autote ... | bluebird bio, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 35 | Phase 3 | France;United States;Germany;Netherlands;Italy;United Kingdom | ||
| 4 | EUCTR2018-001145-14-IT (EUCTR) | 19/04/201920190419 | 02/08/202120210802 | Clinical study to assess the efficacy and safety of gene therapy for the treatment of cerebral adrenoleukodystrophy (CALD) Clinical study to assess the efficacy and safety of gene therapy for the treatment of cerebral adren ... | A Phase 3 Study of Lenti-D Drug Product After Myeloablative Conditioning Using Busulfan and Fludarabine in Subjects inferior or equal to 17 Years of Age With Cerebral Adrenoleukodystrophy (CALD) - ALD-104 A Phase 3 Study of Lenti-D Drug ProductAfter Myeloablative Conditioning Using Busulfan and Fludarabi ... | Cerebral Adrenoleukodystrophy (CALD) MedDRA version: 20.0;Level: PT;Classification code 10051260;Term: Adrenoleukodystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] Cerebral Adrenoleukodystrophy (CALD) MedDRA version: 20.0;Level: PT;Classification code 10051260;Ter ... | Product Name: Lenti-D Drug Product Product Code: [not applicable] INN or Proposed INN: elivaldogene autotemcel Other descriptive name: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA ProductName: Lenti-D Drug Product ProductCode: [not applicable] INN or Proposed INN: elivaldogene auto ... | BLUEBIRD BIO, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 35 | Phase 3 | France;United States;Netherlands;Germany;United Kingdom;Italy | ||
| 5 | EUCTR2018-001145-14-GB (EUCTR) | 17/04/201920190417 | 23/10/201820181023 | Clinical study to assess the efficacy and safety of gene therapy for the treatment of cerebral adrenoleukodystrophy (CALD). Clinical study to assess the efficacy and safety of gene therapy for the treatment of cerebral adren ... | A Phase 3 Study of Lenti-D Drug Product After Myeloablative Conditioning Using Busulfan and Fludarabine in Subjects =17 Years of Age With Cerebral Adrenoleukodystrophy (CALD) A Phase 3 Study of Lenti-D Drug ProductAfter Myeloablative Conditioning Using Busulfan and Fludarabi ... | Cerebral Adrenoleukodystrophy (CALD) MedDRA version: 20.0;Level: PT;Classification code 10051260;Term: Adrenoleukodystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] Cerebral Adrenoleukodystrophy (CALD) MedDRA version: 20.0;Level: PT;Classification code 10051260;Ter ... | Product Name: Lenti-D Drug Product INN or Proposed INN: elivaldogene autotemcel Other descriptive name: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA ProductName: Lenti-D Drug Product INN or Proposed INN: elivaldogene autotemcel Other descriptive name: ... | bluebird bio, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 35 | Phase 3 | United States;France;Netherlands;Germany;Italy;United Kingdom | ||
| 6 | EUCTR2018-001145-14-FR (EUCTR) | 27/03/201920190327 | 23/10/201820181023 | Clinical study to assess the efficacy and safety of gene therapy for the treatment of cerebral adrenoleukodystrophy. Clinical study to assess the efficacy and safety of gene therapy for the treatment of cerebral adren ... | A Phase 3 Study of Lenti-D Drug Product After Myeloablative Conditioning Using Busulfan and Fludarabine in Subjects =17 Years of Age With Cerebral Adrenoleukodystrophy (CALD) A Phase 3 Study of Lenti-D Drug ProductAfter Myeloablative Conditioning Using Busulfan and Fludarabi ... | Cerebral Adrenoleukodystrophy (CALD) MedDRA version: 20.0;Level: PT;Classification code 10051260;Term: Adrenoleukodystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] Cerebral Adrenoleukodystrophy (CALD) MedDRA version: 20.0;Level: PT;Classification code 10051260;Ter ... | Product Name: Lenti-D Drug Product Other descriptive name: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA ProductName: Lenti-D Drug Product Other descriptive name: Autologous haematopoietic stem cells transd ... | bluebird bio, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 20 | Phase 3 | United States;France;Netherlands;Germany;Italy;United Kingdom | ||
| 7 | NCT03852498 (ClinicalTrials.gov) | January 24, 201920190124 | 13/2/201920190213 | A Clinical Study to Assess the Efficacy and Safety of Gene Therapy for the Treatment of Cerebral Adrenoleukodystrophy (CALD) A Clinical Study to Assess the Efficacy and Safety of Gene Therapy for the Treatment of Cerebral Adr ... | A Phase 3 Study of Lenti-D Drug Product After Myeloablative Conditioning Using Busulfan and Fludarabine in Subjects =17 Years of Age With Cerebral Adrenoleukodystrophy (CALD) A Phase 3 Study of Lenti-D Drug ProductAfter Myeloablative Conditioning Using Busulfan and Fludarabi ... | Cerebral Adrenoleukodystrophy (CALD) | Genetic: Lenti-D | bluebird bio | NULL | Active, not recruiting | N/A | 17 Years | Male | 35 | Phase 3 | United States;France;Germany;Italy;Netherlands;United Kingdom |
| 8 | EUCTR2011-001953-10-DE (EUCTR) | 13/07/201820180713 | 11/12/201720171211 | Clinical study to assess the efficacy and safety of gene therapy for the treatment of cerebral adrenoleukodystrophy Clinical study to assess the efficacy and safety of gene therapy for the treatment of cerebral adren ... | A phase 2/3 study of the efficacy and safety of hematopoietic stem cells transduced with Lenti D lentiviral vector for the treatment of cerebral adrenoleukodystrophy (CALD) A phase 2/3 study of the efficacy and safety of hematopoietic stem cells transduced with Lenti D len ... | Cerebral Adrenoleukodystrophy (CALD) MedDRA version: 20.0;Level: PT;Classification code 10051260;Term: Adrenoleukodystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] Cerebral Adrenoleukodystrophy (CALD) MedDRA version: 20.0;Level: PT;Classification code 10051260;Ter ... | Product Name: Lenti-D Drug Product Other descriptive name: AUTOLOGOUS CD34+ CELLS TRANSDUCED WITH LENTI-D VECTOR ENCODING ABCD1 CDNA ProductName: Lenti-D Drug Product Other descriptive name: AUTOLOGOUS CD34+ CELLS TRANSDUCED WITH LENT ... | bluebird bio, Inc. | NULL | Not Recruiting | Female: no Male: yes | 32 | Phase 2;Phase 3 | United States;France;Germany;United Kingdom | ||
| 9 | NCT02698579 (ClinicalTrials.gov) | January 22, 201620160122 | 17/2/201620160217 | Long-term Follow-up of Participants With Cerebral Adrenoleukodystrophy Who Were Treated With Lenti-D Drug Product Long-term Follow-up of Participants With Cerebral Adrenoleukodystrophy Who Were Treated With Lenti-D ... | Long-term Follow-up of Subjects With Cerebral Adrenoleukodystrophy Who Were Treated With Lenti-D Drug Product Long-term Follow-up of Subjects With Cerebral Adrenoleukodystrophy Who Were Treated With Lenti-D Dru ... | Cerebral Adrenoleukodystrophy (CALD);Adrenoleukodystrophy (ALD);X-Linked Adrenoleukodystrophy (X-ALD) Cerebral Adrenoleukodystrophy (CALD);Adrenoleukodystrophy (ALD);X-Linked Adrenoleukodystrophy (X-ALD ... | Genetic: Lenti-D | bluebird bio | NULL | Enrolling by invitation | N/A | N/A | Male | 60 | United States;Argentina;Australia;Brazil;France;Germany;Netherlands;United Kingdom;Algeria | |
| 10 | EUCTR2011-001953-10-FR (EUCTR) | 08/07/201520150708 | 24/06/201520150624 | Clinical study to assess the efficacy and safety of gene therapy for the treatment of childhood cerebral adrenoleukodystrophy Clinical study to assess the efficacy and safety of gene therapy for the treatment of childhood cere ... | A phase 2/3 study of the efficacy and safety of hematopoietic stem cells transduced with Lenti D lentiviral vector for the treatment of childhood cerebral adrenoleukodystrophy (CCALD) A phase 2/3 study of the efficacy and safety of hematopoietic stem cells transduced with Lenti D len ... | Childhood Cerebral Adrenoleukodystrophy (CCALD) MedDRA version: 18.0;Level: PT;Classification code 10051260;Term: Adrenoleukodystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] Childhood Cerebral Adrenoleukodystrophy (CCALD) MedDRA version: 18.0;Level: PT;Classification code 1 ... | Product Name: Lenti-D Drug Product | bluebird bio, Inc. | NULL | Not Recruiting | Female: no Male: yes | 15 | Phase 1;Phase 2;Phase 3 | United States;France;Argentina;Australia;Germany;United Kingdom |