96. クローン病 Crohn disease Clinical trials / Disease details
臨床試験数 : 2,400 / 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215
| 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 | EUCTR2010-019996-32-BG (EUCTR) | 27/04/2011 | 24/02/2011 | A clinical trial to evaluate whether Neovacs' TNFa-Kinoid is effective andsafe for treating adult subjects with moderate to severe Crohn's Disease | A phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease - TNF-K-005 | Moderate to severe Crohn's Disease MedDRA version: 14.0;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: TNFa-Kinoid Product Code: TNF-K INN or Proposed INN: Not assigned yet | Neovacs SA | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 2 | France;Hungary;Czech Republic;Belgium;Croatia;Romania;Bulgaria;Netherlands;Germany | ||
| 2 | EUCTR2010-019996-32-DE (EUCTR) | 31/03/2011 | 22/11/2010 | A clinical trial to evaluate whether Neovacs' TNFa-Kinoid is effective andsafe for treating adult subjects with moderate to severe Crohn's Disease | A phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease | Crohn’s Disease MedDRA version: 16.0;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: TNF-Kinoid Product Code: TNF-K INN or Proposed INN: Not assigned yet | Neovacs SA | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 2 | France;Hungary;Czech Republic;Belgium;Croatia;Romania;Bulgaria;Netherlands;Germany | ||
| 3 | EUCTR2010-019996-32-HU (EUCTR) | 18/03/2011 | 31/01/2011 | A phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease | A phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease | Crohn’s Disease MedDRA version: 12.1;Level: PT;Classification code 10011401;Term: Crohn's disease | Product Name: TNFa-Kinoid Product Code: TNF-K INN or Proposed INN: Not assigned yet | Neovacs SA | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 2 | Hungary;Belgium;Bulgaria;Netherlands;Germany | ||
| 4 | EUCTR2010-019996-32-CZ (EUCTR) | 11/02/2011 | 26/11/2010 | A phase II, randomized, double-blind, placebo-controlled study toevaluate the clinical efficacy, safety and immunogenicity ofNeovacs'TNFa-Kinoid in adult subjects with Crohn's Disease | A phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease | Crohn’s Disease MedDRA version: 14.1;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: TNFa-Kinoid Product Code: TNF-K INN or Proposed INN: Not assigned yet | Neovacs SA | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 2 | France;Hungary;Czech Republic;Belgium;Romania;Croatia;Bulgaria;Netherlands;Germany | ||
| 5 | NCT01291810 (ClinicalTrials.gov) | February 2011 | 17/12/2010 | Clinical Efficacy of TNFa Kinoid in Crohn's Disease Patients | A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy, Safety and Immunogenicity of Neovacs' TNFa-Kinoid in Adult Subjects With Crohn's Disease | Crohn's Disease | Biological: TNF Kinoid;Biological: WFI | Neovacs | NULL | Completed | 18 Years | 65 Years | Both | 66 | Phase 2 | Belgium;Bulgaria;Croatia;Czech Republic;France;Germany;Hungary;Netherlands;Romania |
| 6 | NCT00808262 (ClinicalTrials.gov) | October 2008 | 12/12/2008 | Safety and Immunogenicity of a TNFa Kinoid in Patients With Crohn's Disease | A Phase I/II, Open-label, Escalating Dose, Optimal Two-stage, Study of TNFa-Kinoid (TNF- K) Immunization in Crohn's Disease Patients | Crohn's Disease | Biological: TNFa Kinoid | Neovacs | NULL | Completed | 18 Years | 65 Years | Both | 21 | Phase 1/Phase 2 | South Africa;Switzerland |
| 7 | EUCTR2010-019996-32-NL (EUCTR) | 27/07/2011 | A clinical trial to evaluate whether Neovacs' TNFa-Kinoid is effective and safe for treating adult subjects with moderate to severe Crohn's Disease | A phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’ TNFa-Kinoid in adult subjects with Crohn’s Disease - TNF-K-005 | Moderate to severe Crohn’s Disease MedDRA version: 14.1;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: TNF-Kinoid Product Code: TNF-K INN or Proposed INN: Not assigned yet | Neovacs SA | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 2 | France;Hungary;Czech Republic;Belgium;Croatia;Romania;Bulgaria;Germany;Netherlands |