Darvadstrocel (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 | 11 |
| 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 | NCT04118088 (ClinicalTrials.gov) | January 15, 2021 | 4/10/2019 | Postauthorization Safety Study of Darvadstrocel Repeat Administration | Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn's Disease and Complex Perianal Fistula | Crohn's Disease;Complex Perianal Fistula | Biological: Darvadstrocel | Millennium Pharmaceuticals, Inc. | NULL | Recruiting | 18 Years | N/A | All | 50 | Phase 4 | Austria;Czechia;France;Germany;Spain |
| 2 | EUCTR2017-002491-10-AT (EUCTR) | 19/08/2020 | 11/05/2020 | Postauthorization Safety Study of Darvadstrocel Repeat Administration | Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula | Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Alofisel Product Name: Cx601 Product Code: Cx601 INN or Proposed INN: Darvadstrocel Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs | Millennium Pharmaceuticals, Inc (MPI) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 4 | France;Czech Republic;Spain;Austria;Germany;United Kingdom | ||
| 3 | EUCTR2017-002491-10-FR (EUCTR) | 17/07/2020 | 09/03/2020 | Postauthorization Safety Study of Darvadstrocel Repeat Administration | Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula (ASPIRE) - ASPIRE | Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Alofisel Product Name: Cx601 Product Code: Cx601 INN or Proposed INN: Darvadstrocel Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs | Millennium Pharmaceuticals, Inc (MPI) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 4 | France;Czech Republic;Spain;Austria;Germany;United Kingdom | ||
| 4 | EUCTR2017-002491-10-DE (EUCTR) | 22/06/2020 | 09/03/2020 | Postauthorization Safety Study of Darvadstrocel Repeat Administration | Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula | Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Alofisel Product Name: Cx601 Product Code: Cx601 INN or Proposed INN: Darvadstrocel Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs | Millennium Pharmaceuticals, Inc (MPI) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 4 | France;Czechia;Czech Republic;Spain;Austria;Germany;United Kingdom | ||
| 5 | EUCTR2019-000333-39-BE (EUCTR) | 04/05/2020 | 21/01/2020 | Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex PerianalFistula | A Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn’s Disease Who Have Participated in ADMIRE II Study - Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula | Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Alofisel Product Name: Cx601 Product Code: Cx601 INN or Proposed INN: DARVADSTROCEL Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) | Millennium Pharmaceuticals, Inc (MPI) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 4 | United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy | ||
| 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 |
| 6 | EUCTR2017-002491-10-CZ (EUCTR) | 10/03/2020 | 27/11/2019 | Postauthorization Safety Study of Darvadstrocel Repeat Administration | Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula | Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Alofisel Product Name: Cx601 Product Code: Cx601 INN or Proposed INN: Darvadstrocel Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs | Millennium Pharmaceuticals, Inc (MPI) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 4 | France;Czech Republic;Spain;Austria;Germany;United Kingdom | ||
| 7 | NCT04075825 (ClinicalTrials.gov) | November 4, 2019 | 22/8/2019 | Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula | A Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn's Disease Who Have Participated in ADMIRE II Study | Crohn's Disease;Complex Perianal Fistula | Biological: Darvadstrocel | Millennium Pharmaceuticals, Inc. | NULL | Recruiting | 18 Years | N/A | All | 150 | Phase 3 | United States;Belgium;Czechia;France;Hungary;Israel;Italy;Poland;Spain |
| 8 | EUCTR2019-000333-39-CZ (EUCTR) | 15/10/2019 | 03/09/2019 | Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula | A Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn’s Disease Who Have Participated in ADMIRE II Study - Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula | Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Alofisel Product Name: Cx601 Product Code: Cx601 INN or Proposed INN: DARVADSTROCEL Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) | Millennium Pharmaceuticals, Inc (MPI) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 4 | United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy | ||
| 9 | NCT03706456 (ClinicalTrials.gov) | March 6, 2019 | 11/10/2018 | Phase 3 Study of Cx601 in Subjects With Complex Perianal Fistulising Crohn's Disease | A Phase 3, Multicenter, Open-Label, Uncontrolled Study to Evaluate the Efficacy and Safety of Cx601 in the Treatment of Complex Perianal Fistulas in Adult Patients With Crohn's Disease | Complex Perianal Fistulas in Adult Patients With Crohn's Disease | Biological: Darvadstrocel | Takeda | NULL | Active, not recruiting | 18 Years | N/A | All | 22 | Phase 3 | Japan |
| 10 | EUCTR2019-000333-39-FR (EUCTR) | 04/10/2019 | Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula | A Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn’s Disease Who Have Participated in ADMIRE II Study - Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula | Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Alofisel Product Name: Cx601 Product Code: Cx601 INN or Proposed INN: DARVADSTROCEL Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) | Millennium Pharmaceuticals, Inc (MPI) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 4 | United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy | |||
| 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 |
| 11 | EUCTR2020-003193-48-NL (EUCTR) | 21/11/2020 | A Phase 3 Study to Evaluate the Efficacy and Safety of Darvadstrocel in the Treatment of Complex Perianal Fistula in Pediatric Subjects with Crohn’s Disease. | A Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Darvadstrocel inthe Treatment of Complex Perianal Fistula in Pediatric Subjects with Crohn’s Disease over aPeriod of 24 Weeks and an Extended Follow-up Period for a Total of up to 52 Weeks. - Darvadstrocel in the Treatment of Complex Perianal Fistula in Pediatric Crohn’s Disease. | Complex Perianal Fistulas in Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10068659;Term: Perianal fistula;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Alofisel Product Name: Darvadstrocel Product Code: Cx601 INN or Proposed INN: Darvadstrocel Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) | Takeda Development Center Americas, Inc. | NULL | NA | Female: yes Male: yes | 20 | Phase 3 | Spain;Poland;Israel;Netherlands;Japan;Italy |