DARVADSTROCEL
( DrugBank: Darvadstrocel / KEGG DRUG: Darvadstrocel )
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 | 19 |
96. クローン病
臨床試験数 : 2,442 / 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
Showing 1 to 10 of 19 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 | NCT05113095 (ClinicalTrials.gov) | November 30, 202120211130 | 5/11/202120211105 | A Survey of Darvadstrocel in People With Crohn's Disease | Postmarketing Surveillance Registry to Evaluate Safety and Efficacy of Darvadstrocel for the Treatment of Complex Perianal Fistulas in Crohn's Disease Patients (J-INSPIRE) (All-case Surveillance) Postmarketing Surveillance Registry to Evaluate Safety and Efficacy of Darvadstrocelfor the Treatmen ... | Crohn's Disease | Biological: Darvadstrocel | Takeda | NULL | Recruiting | 20 Years | N/A | All | 275 | Japan | |
| 2 | JPRN-jRCT2033200314 (jRCT2033200314) | 30/06/202120210630 | 20/01/202120210120 | A Study of Darvadstrocel for Treating of Complex Perianal Fistula in Children and Teenagers With Crohn's Disease A Study of Darvadstrocelfor Treating of Complex Perianal Fistula in Children and Teenagers With Croh ... | A Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Darvadstrocel in the Treatment of Complex Perianal Fistula in Pediatric Subjects with Crohn's Disease over a Period of 24 Weeks and an Extended Follow-up Period for a Total of up to 52 Weeks A Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Darvadstrocelin the ... | Crohn's Disease, Complex Perianal Fistula | Darvadstrocel (Cx601), 24 mL suspension of 120 million cells as a perilesional injection, once on Day 0. Darvadstrocel(Cx601), 24 mL suspension of 120 million cells as a perilesional injection, once on Day ... | Shikamura Mitsuhiro | NULL | Recruiting | >= 4age old | < 18age old | Both | 20 | Phase 3 | Italy;Netherlands;Poland;Spain;Israel;Japan |
| 3 | NCT04701411 (ClinicalTrials.gov) | June 30, 202120210630 | 6/1/202120210106 | A Study of Darvadstrocel for Treating Complex Perianal Fistulas in Children and Teenagers With Crohn's Disease A Study of Darvadstrocelfor Treating Complex Perianal Fistulas in Children and Teenagers With Crohn' ... | A Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Darvadstrocel in the Treatment of Complex Perianal Fistula in Pediatric Subjects With Crohn's Disease Over a Period of 24 Weeks and an Extended Follow-up Period for a Total of up to 52 Weeks A Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Darvadstrocelin the ... | Crohn's Disease;Complex Perianal Fistula | Biological: Darvadstrocel | Takeda | Takeda Development Center Americas, Inc. | Recruiting | 4 Years | 17 Years | All | 20 | Phase 3 | Israel;Japan;Netherlands;Poland;Spain |
| 4 | EUCTR2017-000725-12-DK (EUCTR) | 07/04/202120210407 | 14/10/202020201014 | A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD). A clinical research study of an investigational new drug to treat perianal fistulas in patients with ... | A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study. A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentr ... | 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] Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Ter ... | Trade Name: Alofisel Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601 Product Code: Cx601 INN or Proposed INN: Darvadstrocel Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) Trade Name: Alofisel Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601 P ... | TiGenix, S.A.U. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 554 | Phase 3 | United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Sweden United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium ... | ||
| 5 | EUCTR2020-003193-48-NL (EUCTR) | 25/01/202120210125 | 21/11/202020201121 | 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 Study to Evaluate the Efficacy and Safety of Darvadstrocelin the Treatment of Complex Peri ... | 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. A Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Darvadstrocelinthe T ... | 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] Complex Perianal Fistulas in Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 100 ... | 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) Trade Name: Alofisel Product Name: Darvadstrocel Product Code: Cx601 INN or Proposed INN: Darvadstrocel ... | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 3 | Spain;Poland;Israel;Netherlands;Italy;Japan | ||
| 6 | NCT04118088 (ClinicalTrials.gov) | December 22, 202020201222 | 4/10/201920191004 | A Study of Darvadstrocel in Adults With Crohn's Disease and Complex Perianal Fistula | 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 Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darv ... | Crohn's Disease;Complex Perianal Fistula | Biological: Darvadstrocel | Takeda | Takeda Development Center Americas, Inc. | Recruiting | 18 Years | N/A | All | 50 | Phase 4 | Austria;Czechia;France;Germany;Israel;Spain |
| 7 | EUCTR2019-000333-39-FR (EUCTR) | 07/11/202020201107 | 04/10/201920191004 | 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 A Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocelin the ... | 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] Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Ter ... | 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) Trade Name: Alofisel Product Name: Cx601 Product Code: Cx601 INN or Proposed INN: DARVADSTROCEL Other de ... | 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 United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdo ... | ||
| 8 | EUCTR2017-002491-10-AT (EUCTR) | 19/08/202020200819 | 11/05/202020200511 | 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 Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darv ... | 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] Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Ter ... | 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 Trade Name: Alofisel Product Name: Cx601 Product Code: Cx601 INN or Proposed INN: Darvadstrocel Other de ... | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 4 | France;Czechia;Czech Republic;Spain;Austria;Israel;Germany | ||
| 9 | EUCTR2017-002491-10-FR (EUCTR) | 17/07/202020200717 | 09/03/202020200309 | 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 Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darv ... | 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] Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Ter ... | 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 Trade Name: Alofisel Product Name: Cx601 Product Code: Cx601 INN or Proposed INN: Darvadstrocel Other de ... | 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 | ||
| 10 | EUCTR2017-002491-10-DE (EUCTR) | 22/06/202020200622 | 09/03/202020200309 | 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 Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darv ... | 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] Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Ter ... | 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 Trade Name: Alofisel Product Name: Cx601 Product Code: Cx601 INN or Proposed INN: Darvadstrocel Other de ... | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 4 | France;Czechia;Czech Republic;Spain;Austria;Israel;Germany |