G1XCG ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
65原発性免疫不全症候群5

65. 原発性免疫不全症候群


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.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
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Recruitment_
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Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1NCT02757911
(ClinicalTrials.gov)
March 201620/4/2016Gene Therapy for X-linked Chronic Granulomatous DiseaseA Phase I/II, Non Randomized, Monocentric Open-label Study of Autologous CD34+ Cells Transduced With the G1XCGD Lentiviral Vector in Patients With X-Linked Chronic Granulomatous DiseaseX-Linked Chronic Granulomatous DiseaseGenetic: X vivo gene therapyGenethonNULLActive, not recruiting24 MonthsN/AMale3Phase 1/Phase 2France
2EUCTR2012-000242-35-DE
(EUCTR)
23/12/201329/04/2013Gene therapy with autologous genetically-modified CD34+ cells for X-linked Chronic Granulomatous Disease (X-CGD)A phase I/II, non randomized, multicenter, open-label study of autologous CD34+ cells transduced with the G1XCGD Lentiviral vector in patients with X-Linked Chronic Granulomatous Disease - Phase I/II G1XCGD.01 study : an ex-vivo gene therapy for X-CGD patients X-linked Chronic Granulomatous Disease
MedDRA version: 14.1;Level: PT;Classification code 10008906;Term: Chronic granulomatous disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Suspension of autologous CD34+cells transduced with the G1XCGD viral vector
Product Code: G1XCGD transduced CD34+ cells
Other descriptive name: AUTOLOGOUS CD34+ CELLS TRANSDUCED EX-VIVO WITH THE PCCLCHIMGP91/VSVG LENTIVIRAL VECTOR
GENETHONNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
20Phase 1/2France;Germany;United Kingdom;Switzerland
3NCT01855685
(ClinicalTrials.gov)
June 24, 201314/5/2013Gene Therapy for X-linked Chronic Granulomatous Disease (X-CGD)A Phase I/II, Non Randomized, Multicenter, Open-label Study of Autologous CD34+ Cells Transduced With the G1XCGD Lentiviral Vector in Patients With X-linked Chronic Granulomatous DiseaseX-Linked Chronic Granulomatous DiseaseGenetic: X vivo gene therapyGenethonNULLActive, not recruiting6 MonthsN/AMale3Phase 1/Phase 2United Kingdom;Germany;Switzerland
4EUCTR2012-001725-26-DE
(EUCTR)
12/03/201318/12/2012A Phase I/II Gene Therapy trial for X-CGD with a SIN gamma retroviral vectorA Phase I/II Gene Therapy trial for X-CGD with a SIN gamma retroviral vector - gene therapy for X-CGD Chronic granulomatous disease (CGD) is a congenital immunodeficiency, in which neutrophil granulocytes and monocytes are not capable of producing reactive oxygen species and therefore are unable to kill phagocytized bacteria or fungi.
MedDRA version: 14.1;Level: PT;Classification code 10008906;Term: Chronic granulomatous disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: genetically modified autologous blood stem cells
Product Code: somatic gene-therapy by X-CGD
INN or Proposed INN: G1XCG
Other descriptive name: Genetically modified autologous blood stem cells
Johann Wolfgang Goethe-UniversityNULLNot RecruitingFemale: yes
Male: yes
5Phase 1;Phase 2Germany
5EUCTR2012-000242-35-GB
(EUCTR)
10/01/201319/07/2012Gene therapy with autologous genetically-modified CD34+ cells for X-linked Chronic Granulomatous DiseaseA phase I/II, non randomized, multicenter, open-label study of autologous CD34+ cells transduced with the G1XCGD Lentiviral vector in patients withX-Linked Chronic Granulomatous Disease - Phase I/II G1XCGD.01 study : an ex-vivo gene therapy for X-CGD patients X-linked Chronic Granulomatous Disease
MedDRA version: 19.0;Level: PT;Classification code 10008906;Term: Chronic granulomatous disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Suspension of autologous CD34+cells transduced with the G1XCGD viral vector
Product Code: G1XCGD transduced CD34+ cells
Other descriptive name: AUTOLOGOUS CD34+ CELLS TRANSDUCED EX-VIVO WITH THE PCCLCHIMGP91/VSVG LENTIVIRAL VECTOR
GenethonNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
11Phase 1;Phase 2France;Germany;Switzerland;United Kingdom