Hum291 (DrugBank: -)
2 diseases| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 96 | Crohn disease | 3 |
| 97 | Ulcerative colitis | 29 |
| 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 | EUCTR2004-004387-72-AT (EUCTR) | 11/10/2005 | 09/06/2005 | A Phase IIa, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients with Crohn’s Disease. - N/A | A Phase IIa, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients with Crohn’s Disease. - N/A | Crohn’s disease (CD) in patients with at least one perianal fistula. MedDRA version: 7.1;Level: LLT;Classification code 10011401 | Product Name: Visilizumab Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: Anti-CD3 Monoclonal antibody | Protein Design Labs, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2a | Austria;Germany | ||
| 2 | EUCTR2004-004388-31-DE (EUCTR) | 03/06/2005 | 07/01/2005 | A Phase IIa, Open-label Study of Visilizumab in Patients with Moderate-to-Severe Inflammatory, Nonstricturing, Nonpenetrating Forms of Crohn’s Disease - N/A | A Phase IIa, Open-label Study of Visilizumab in Patients with Moderate-to-Severe Inflammatory, Nonstricturing, Nonpenetrating Forms of Crohn’s Disease - N/A | Moderate-to-severe inflammatory, nonstricturing, nonpenetrating Crohn’s disease (CD). MedDRA version: 7.1;Level: LLT;Classification code 10011401 | Product Name: Visilizumab Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: Anti-CD3 Monoclonal antibody | PDL BioPharma, Inc | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2a | Germany | ||
| 3 | EUCTR2004-004387-72-DE (EUCTR) | 03/06/2005 | 07/01/2005 | A Phase IIa, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients with Crohn’s Disease. - N/A | A Phase IIa, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients with Crohn’s Disease. - N/A | Crohn’s disease (CD) in patients with at least one perianal fistula. MedDRA version: 7.1;Level: LLT;Classification code 10011401 | Product Name: Visilizumab Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: Anti-CD3 Monoclonal antibody | PDL BioPharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2a | Germany |
| 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 | EUCTR2005-003707-37-BE (EUCTR) | 25/05/2007 | 18/12/2006 | A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Belgium;Austria | ||
| 2 | EUCTR2005-003707-37-AT (EUCTR) | 09/05/2007 | 03/01/2007 | A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Belgium;Austria | ||
| 3 | EUCTR2005-004105-28-FR (EUCTR) | 26/04/2007 | 23/02/2007 | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ S | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ S | Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Hungary;Germany;United Kingdom;Netherlands;France;Ireland;Greece | |||
| 4 | EUCTR2005-004105-28-GR (EUCTR) | 15/03/2007 | 15/02/2007 | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ S | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ S | Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Germany;United Kingdom;Netherlands;France;Ireland;Greece | |||
| 5 | EUCTR2005-003482-17-GB (EUCTR) | 26/02/2007 | 01/02/2006 | A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 2 | United Kingdom;Spain;Ireland;Italy;Greece | ||
| 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 | EUCTR2005-003481-42-GR (EUCTR) | 30/01/2007 | 24/11/2006 | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Hungary;Germany;Czech Republic;Slovakia;Spain;Ireland;Italy;Greece | |||
| 7 | EUCTR2005-003482-17-GR (EUCTR) | 30/01/2007 | 24/11/2006 | A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ D | A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ D | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United Kingdom;Spain;Ireland;Italy;Greece | ||
| 8 | NCT00502294 (ClinicalTrials.gov) | January 2007 | 13/7/2007 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous Steroid-Refractory Ulcerative Colitis | Drug: Visilizumab (HuM291; Nuvion®) | Facet Biotech | PDL BioPharma, Inc. | Withdrawn | 18 Years | N/A | Both | 150 | Phase 3 | NULL |
| 9 | EUCTR2005-004105-28-DE (EUCTR) | 11/10/2006 | 10/04/2006 | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ S | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ S | Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;United Kingdom;Germany;Netherlands;France;Ireland;Greece | |||
| 10 | EUCTR2005-004105-28-NL (EUCTR) | 28/09/2006 | 10/08/2006 | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti CD3 monoclonal antibody | PDL BioPharma, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Hungary;Germany;United Kingdom;Netherlands;France;Ireland;Greece | |||
| 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 | NCT00355901 (ClinicalTrials.gov) | September 2006 | 21/7/2006 | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis | Ulcerative Colitis | Drug: Visilizumab (Nuvion®; HuM291) | PDL BioPharma, Inc. | NULL | Terminated | 18 Years | N/A | Both | 300 | United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Hungary;Ireland;Italy;Netherlands;Norway;Ukraine | |
| 12 | EUCTR2005-004105-28-GB (EUCTR) | 20/06/2006 | 07/03/2006 | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis. | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis. | Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC). MedDRA version: 8.0;Level: LLT;Classification code 10045265 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Germany;United Kingdom;Netherlands;France;Ireland;Greece | |||
| 13 | EUCTR2005-004105-28-IE (EUCTR) | 20/06/2006 | 10/02/2006 | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis. | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis. | Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC). MedDRA version: 8.0;Level: LLT;Classification code 10045265 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | France;Hungary;Greece;Ireland;Netherlands;Germany;United Kingdom | ||
| 14 | EUCTR2005-003482-17-IT (EUCTR) | 08/06/2006 | 04/12/2006 | A Phase 2, Randomized, Double-Blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intraveneous Steroid-Refractory Ulcerative Colitis. | A Phase 2, Randomized, Double-Blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intraveneous Steroid-Refractory Ulcerative Colitis. | Subjects with Intraveneous Steroid-Refractory Ulcerative Colitis MedDRA version: 6.1;Level: PT;Classification code 10009900 | Product Name: visilizumab Product Code: HuM291 Product Name: visilizumab Product Code: HuM291 Product Name: visilizumab Product Code: HuM291 | PDL BioPharma , Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United Kingdom;Spain;Ireland;Italy;Greece | ||
| 15 | EUCTR2005-003482-17-ES (EUCTR) | 26/05/2006 | 15/03/2006 | A Phase 2, Randomized, Double-blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisEstudio fase 2, aleatorizado, doble ciego, multicéntrico, de exploración de dosis de Visilizumab en sujetos con colitis ulcerosa refractaria a esteróides intravenosos. | A Phase 2, Randomized, Double-blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisEstudio fase 2, aleatorizado, doble ciego, multicéntrico, de exploración de dosis de Visilizumab en sujetos con colitis ulcerosa refractaria a esteróides intravenosos. | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 8.0;Level: LLT;Classification code 10045265 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United Kingdom;Ireland;Spain;Italy;Greece | ||
| 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 |
| 16 | EUCTR2005-003481-42-ES (EUCTR) | 26/05/2006 | 15/03/2006 | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab StudyEstudio aleatorizado, doble ciego y multicéntrico de Visilizumab frente a placebo en sujetos con colitis ulcerosa refractaria a esteroides intravenosos que hayan respondido previamente en un estudio con Visilizumab. | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab StudyEstudio aleatorizado, doble ciego y multicéntrico de Visilizumab frente a placebo en sujetos con colitis ulcerosa refractaria a esteroides intravenosos que hayan respondido previamente en un estudio con Visilizumab. | Intravenous steroid-refractory ulcerative colitis (IVSR-UC)Colitis ulcerosa refractaria a esteróides intravenonsos MedDRA version: 8.0;Level: LLT;Classification code 10045265 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Hungary;Germany;Czech Republic;Slovakia;Ireland;Spain;Italy;Greece | |||
| 17 | EUCTR2005-003481-42-SK (EUCTR) | 21/04/2006 | 25/11/2005 | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | Protein Design Labs, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | Czech Republic;Hungary;Slovakia;Greece;Spain;Ireland;Austria;Germany | ||
| 18 | EUCTR2005-002063-87-HU (EUCTR) | 04/04/2006 | 02/05/2007 | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: visilizumab Other descriptive name: anti-CD3 monoclonal antibody | Protein Design Labs, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2;Phase 3 | Hungary;Germany;Czech Republic;Belgium | ||
| 19 | EUCTR2005-003481-42-HU (EUCTR) | 04/04/2006 | 28/11/2005 | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Hungary;Germany;Czech Republic;Slovakia;Spain;Ireland;Italy;Greece | |||
| 20 | EUCTR2005-003481-42-IE (EUCTR) | 04/04/2006 | 10/01/2006 | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Czech Republic;Hungary;Slovakia;Greece;Spain;Ireland;Austria;Germany | ||
| 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 |
| 21 | EUCTR2005-002063-87-DE (EUCTR) | 22/03/2006 | 29/11/2005 | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2;Phase 3 | Hungary;Czech Republic;Germany;Belgium | ||
| 22 | EUCTR2005-003481-42-DE (EUCTR) | 22/03/2006 | 29/11/2005 | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Hungary;Czech Republic;Slovakia;Germany;Spain;Ireland;Italy;Greece | |||
| 23 | EUCTR2005-002063-87-SK (EUCTR) | 16/03/2006 | 23/11/2005 | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2;Phase 3 | Hungary;Czech Republic;Slovakia;Belgium;Austria;Germany | ||
| 24 | EUCTR2005-003482-17-IE (EUCTR) | 03/03/2006 | 10/01/2006 | A Phase 2, Randomized, Double-blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 2, Randomized, Double-blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 8.0;Level: LLT;Classification code 10045265 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Greece;Spain;Ireland;Italy;United Kingdom | ||
| 25 | EUCTR2005-002063-87-CZ (EUCTR) | 16/02/2006 | 28/11/2005 | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2;Phase 3 | Hungary;Germany;Czech Republic;Belgium | ||
| 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 |
| 26 | EUCTR2005-003481-42-CZ (EUCTR) | 16/02/2006 | 28/11/2005 | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Hungary;Germany;Slovakia;Czech Republic;Spain;Ireland;Italy;Greece | |||
| 27 | EUCTR2005-002063-87-BE (EUCTR) | 09/02/2006 | 24/11/2005 | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: visilizumab Other descriptive name: anti-CD3 monoclonal antibody | Protein Design Labs, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2;Phase 3 | Hungary;Germany;Czech Republic;Belgium | ||
| 28 | EUCTR2005-003481-42-AT (EUCTR) | 04/01/2006 | 30/11/2005 | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | Protein Design Labs, Inc | NULL | Not Recruiting | Female: yes Male: yes | 80 | Czech Republic;Hungary;Slovakia;Greece;Spain;Ireland;Austria;Germany | |||
| 29 | EUCTR2005-002063-87-AT (EUCTR) | 28/12/2005 | 23/11/2005 | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: visilizumab Other descriptive name: anti-CD3 monoclonal antibody | Protein Design Labs, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2;Phase 3 | Hungary;Czech Republic;Belgium;Austria;Germany |