65. Primary immunodeficiency Clinical trials / Disease details
Clinical trials : 500 / Drugs : 614 - (DrugBank : 119) / Drug target genes : 92 - Drug target pathways : 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 | NCT02757911 (ClinicalTrials.gov) | March 2016 | 20/4/2016 | Gene Therapy for X-linked Chronic Granulomatous Disease | A 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 Disease | X-Linked Chronic Granulomatous Disease | Genetic: X vivo gene therapy | Genethon | NULL | Active, not recruiting | 24 Months | N/A | Male | 3 | Phase 1/Phase 2 | France |
| 2 | EUCTR2012-000242-35-DE (EUCTR) | 23/12/2013 | 29/04/2013 | Gene 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 | GENETHON | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 20 | Phase 1/2 | France;Germany;United Kingdom;Switzerland | ||
| 3 | NCT01855685 (ClinicalTrials.gov) | June 24, 2013 | 14/5/2013 | Gene 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 Disease | X-Linked Chronic Granulomatous Disease | Genetic: X vivo gene therapy | Genethon | NULL | Active, not recruiting | 6 Months | N/A | Male | 3 | Phase 1/Phase 2 | United Kingdom;Germany;Switzerland |
| 4 | EUCTR2012-001725-26-DE (EUCTR) | 12/03/2013 | 18/12/2012 | A Phase I/II Gene Therapy trial for X-CGD with a SIN gamma retroviral vector | A 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-University | NULL | Not Recruiting | Female: yes Male: yes | 5 | Phase 1;Phase 2 | Germany | ||
| 5 | EUCTR2012-000242-35-GB (EUCTR) | 10/01/2013 | 19/07/2012 | Gene therapy with autologous genetically-modified CD34+ cells for X-linked Chronic Granulomatous Disease | A 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 | Genethon | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 11 | Phase 1;Phase 2 | France;Germany;Switzerland;United Kingdom |