Ovasave (DrugBank: -)
1 disease| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 96 | クローン病 | 5 |
| 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 | EUCTR2014-001295-65-AT (EUCTR) | 01/12/2014 | 19/11/2014 | Phase II study evaluating Ovasave, a cell therapy, in patient with active Crohn's Disease | A phase IIb, multicentre, randomised, double-blinded (DB), placebo-controlled, single-dose and multi-injection, parallel groups study to evaluate the efficacy and the safety of Ovasave (ovalbumin-specific autologous Treg cells (ova-Treg)) in patients with active refractory Crohn’s Disease (Crohn’s And Treg Study: CATS29) - CATS29 | Moderately to severely active Crohn's Disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Ovasave INN or Proposed INN: Ova-Treg Other descriptive name: Autologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population | TxCell | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 2 | Belgium;Austria;Germany;Italy | ||
| 2 | EUCTR2014-001295-65-IT (EUCTR) | 01/12/2014 | 27/11/2014 | Phase II study evaluating Ovasave, a cell therapy, in patient with active Crohn's Disease | A phase IIb, multicentre, randomised, double-blinded (DB), placebo-controlled, multi-dose and multi-injection, parallel groups study to evaluate the efficacy and the safety of Ovasave (ovalbumin-specific autologous Treg cells (ova-Treg)) in patients with active refractory Crohn’s Disease (Crohn’s And Treg Study: CATS29) - CATS29 | Moderately to severely active Crohn's Disease MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Ovasave INN or Proposed INN: Ova-Treg Other descriptive name: Autologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population Product Name: Ovasave INN or Proposed INN: Ova-Treg Other descriptive name: Autologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population Product Name: Ovasave INN or Proposed INN: Ova-Treg Other descriptive name: Autologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population | TxCell | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Belgium;Austria;Germany;Italy | ||
| 3 | NCT02327221 (ClinicalTrials.gov) | December 2014 | 23/12/2014 | Study Evaluating Ovasave, an Autologous Cell Therapy, in Patients With Active Crohn's Disease | A Phase IIb, Multicentre, Randomised, Double-blinded, Placebo-controlled, Multi-dose and Multi-injection, Parallel Groups Study to Evaluate the Efficacy and the Safety of Ovasave in Patients With Active Refractory Crohn's Disease | Crohn Disease | Drug: Ovasave;Drug: Placebo | TxCell | NULL | Terminated | 18 Years | 70 Years | All | 32 | Phase 2 | Austria;Belgium;France;Germany;Italy;United Kingdom |
| 4 | EUCTR2014-001295-65-BE (EUCTR) | 28/11/2014 | 17/11/2014 | Phase II study evaluating Ovasave, a cell therapy, in patient with active Crohn's Disease | A phase IIb, multicentre, randomised, double-blinded (DB), placebo-controlled, single-dose and parallel-group study to evaluate the efficacy and the safety of Ovasave (ovalbumin-specific autologous Treg cells (Ova-Treg)) in patients with active refractory Crohn's Disease (Crohn's And Treg Study: CATS29) - CATS29 | Moderately to severely active Crohn's Disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Ovasave INN or Proposed INN: Ova-Treg Other descriptive name: Autologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population | TxCell | NULL | Not Recruiting | Female: yes Male: yes | 117 | Phase 2 | Belgium;Austria;Germany;Italy | ||
| 5 | EUCTR2014-001295-65-DE (EUCTR) | 25/11/2014 | 19/11/2014 | Phase II study evaluating Ovasave, a cell therapy, in patient with active Crohn's Disease | A phase IIb, multicentre, randomised, double-blinded (DB), placebo-controlled, single-dose and multi-injection, parallel groups study to evaluate the efficacy and the safety of Ovasave (ovalbumin-specific autologous Treg cells (ova-Treg)) in patients with active refractory Crohn’s Disease (Crohn’s And Treg Study: CATS29) - CATS29 | Moderately to severely active Crohn's Disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Ovasave INN or Proposed INN: Ova-Treg Other descriptive name: Autologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population | TxCell | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 2 | Belgium;Austria;Germany;Italy |