66. IgA腎症 IgA nephropathy Clinical trials / Disease details
臨床試験数 : 255 / 薬物数 : 255 - (DrugBank : 79) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 137
| 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 | EUCTR2014-001365-26-IT (EUCTR) | 05/06/2015 | 23/03/2015 | A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy | A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration | IgA Nephropathy MedDRA version: 17.1;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Blisibimod Injection Product Code: A-623 or AMG 623 INN or Proposed INN: blisibimod | Anthera pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2/3 | Portugal;Belarus;Philippines;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Italy;France;Malaysia;Netherlands;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Georgia;Germany;Japan;Sweden | ||
| 2 | EUCTR2014-001365-26-ES (EUCTR) | 27/05/2015 | 27/03/2015 | A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy | A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - BRIGHT-SC: Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration | IgA Nephropathy MedDRA version: 17.1;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Blisibimod Injection Product Code: A-623 or AMG 623 INN or Proposed INN: blisibimod | Anthera pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2;Phase 3 | Portugal;Belarus;Philippines;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Italy;France;Malaysia;Netherlands;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Georgia;Germany;Japan;Sweden | ||
| 3 | EUCTR2014-001365-26-HU (EUCTR) | 11/05/2015 | 25/03/2015 | A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy | A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - BRIGHT-SC: Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration | IgA Nephropathy MedDRA version: 17.1;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Blisibimod Injection Product Code: A-623 or AMG 623 INN or Proposed INN: blisibimod | Anthera pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2/3 | Belarus;Portugal;Philippines;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Italy;France;Malaysia;Netherlands;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Georgia;Bulgaria;Germany;Japan;Sweden | ||
| 4 | EUCTR2014-001365-26-SE (EUCTR) | 11/05/2015 | 25/03/2015 | A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy | A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - BRIGHT-SC: Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration | IgA Nephropathy MedDRA version: 18.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Blisibimod Injection Product Code: A-623 or AMG 623 INN or Proposed INN: blisibimod | Anthera pharmaceuticals, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2/3 | Belarus;Philippines;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Italy;France;Malaysia;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Georgia;Germany;Japan;Sweden | ||
| 5 | EUCTR2014-001365-26-DE (EUCTR) | 02/02/2015 | 07/08/2014 | A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy | A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - BRIGHT-SC: Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration | IgA Nephropathy MedDRA version: 19.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Blisibimod Injection Product Code: A-623 or AMG 623 INN or Proposed INN: blisibimod | Anthera pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2;Phase 3 | Belarus;Philippines;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Italy;France;Malaysia;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Georgia;Germany;Japan;Sweden | ||
| 6 | NCT02052219 (ClinicalTrials.gov) | October 2014 | 29/1/2014 | BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy | A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy | IgA Nephropathy | Drug: Blisibimod;Drug: Placebo | Anthera Pharmaceuticals | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 3 | NULL |
| 7 | EUCTR2014-001365-26-CZ (EUCTR) | 21/08/2014 | 22/05/2014 | A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy | A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - BRIGHT-SC: Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration | IgA Nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Blisibimod Injection Product Code: A-623 or AMG 623 INN or Proposed INN: blisibimod | Anthera Pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2;Phase 3 | Philippines;Taiwan;Hong Kong;Spain;Thailand;United Kingdom;Italy;Hungary;Czech Republic;Canada;Malaysia;Singapore;Germany;Japan;Sweden;Korea, Republic of | ||
| 8 | NCT02062684 (ClinicalTrials.gov) | June 2013 | 12/2/2014 | BRIGHT-SC: Blisibimod Response in IgA Nephropathy Following At-Home Treatment by Subcutaneous Administration | A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy | IgA Nephropathy | Drug: Blisibimod;Drug: Placebo | Anthera Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | All | 57 | Phase 2/Phase 3 | Czechia;Germany;Hong Kong;Korea, Republic of;Malaysia;Philippines;Singapore;Taiwan;Thailand;United Kingdom;Canada;Czech Republic;Italy;Russian Federation;Spain |