IgPro20 ( DrugBank: - )
4 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 14 | 慢性炎症性脱髄性多発神経炎／多巣性運動ニューロパチー | 21 |
| 50 | 皮膚筋炎／多発性筋炎 | 7 |
| 51 | 全身性強皮症 | 4 |
| 65 | 原発性免疫不全症候群 | 26 |
14. 慢性炎症性脱髄性多発神経炎／多巣性運動ニューロパチー
臨床試験数 : 175 / 薬物数 : 161 - (DrugBank : 41) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 24
| 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 | EUCTR2011-003448-28-PL (EUCTR) | 07/07/2015 | 06/05/2015 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 19.0;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan | ||
| 2 | EUCTR2011-003448-28-EE (EUCTR) | 11/06/2015 | 14/05/2015 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan | ||
| 3 | EUCTR2011-003448-28-LT (EUCTR) | 09/06/2015 | 21/04/2015 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.0;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan | ||
| 4 | EUCTR2013-004157-24-CZ (EUCTR) | 12/03/2015 | 24/03/2014 | Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP) | Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.0;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) Other descriptive name: Hizentra® | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Netherlands;Germany;Italy;Japan | ||
| 5 | EUCTR2013-004157-24-NL (EUCTR) | 02/12/2014 | 20/03/2014 | Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP) | Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) Other descriptive name: Hizentra® | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Germany;Netherlands;Italy;Japan | ||
| 6 | EUCTR2013-004157-24-IT (EUCTR) | 01/10/2014 | 21/02/2014 | Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP) | Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 16.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) Other descriptive name: Hizentra® | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Israel;Netherlands;Germany;Japan;Italy | ||
| 7 | NCT02027701 (ClinicalTrials.gov) | July 30, 2014 | 3/1/2014 | Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Multicenter, Open-label Extension Study to Investigate the Long-term Safety and Efficacy of IgPro20 in Maintenance Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Subjects Completing Study IgPro20_3003 | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP);Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | Biological: IgPro20 | CSL Behring | NULL | Completed | 18 Years | N/A | All | 82 | Phase 3 | United States;Australia;Canada;Czechia;France;Germany;Italy;Japan;Netherlands;Spain;United Kingdom;Czech Republic;Finland |
| 8 | EUCTR2013-004157-24-DE (EUCTR) | 05/06/2014 | 25/02/2014 | Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP) | Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 19.0;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) Other descriptive name: Hizentra® | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Netherlands;Germany;Italy;Japan | ||
| 9 | EUCTR2013-004157-24-GB (EUCTR) | 30/04/2014 | 18/02/2014 | Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP) | Multicenter, open-label extension study to investigate the long-term safety and efficacy of IgPro20 in maintenance treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in subjects completing study IgPro20_3003 | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) Other descriptive name: Hizentra® | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 80 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Netherlands;Germany;Italy;Japan;United Kingdom | ||
| 10 | EUCTR2013-004157-24-ES (EUCTR) | 23/04/2014 | 27/02/2014 | Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP) | Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 16.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) Other descriptive name: Hizentra® | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Israel;Netherlands;Germany;Italy;Japan | ||
| 11 | EUCTR2013-004157-24-FI (EUCTR) | 04/04/2014 | 19/03/2014 | Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP) | Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 17.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) Other descriptive name: Hizentra® | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Netherlands;Germany;Italy;Japan | ||
| 12 | EUCTR2011-003448-28-BE (EUCTR) | 27/09/2012 | 02/04/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan | ||
| 13 | EUCTR2011-003448-28-IT (EUCTR) | 23/08/2012 | 29/03/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallelgroup phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 14.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN | CSL BEHRING GMBH | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Switzerland;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Netherlands;Korea, Republic of | ||
| 14 | EUCTR2011-003448-28-GB (EUCTR) | 23/05/2012 | 29/03/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan | ||
| 15 | EUCTR2011-003448-28-AT (EUCTR) | 18/05/2012 | 16/03/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 14.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Belgium;Australia;Netherlands;Germany;Korea, Republic of | ||
| 16 | EUCTR2011-003448-28-NL (EUCTR) | 11/05/2012 | 14/03/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 17.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan | ||
| 17 | EUCTR2011-003448-28-CZ (EUCTR) | 09/05/2012 | 23/02/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan | ||
| 18 | EUCTR2011-003448-28-ES (EUCTR) | 24/04/2012 | 29/02/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP)-the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 14.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Korea, Republic of | ||
| 19 | EUCTR2011-003448-28-DE (EUCTR) | 20/04/2012 | 31/01/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 19.0;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan | ||
| 20 | EUCTR2011-003448-28-FI (EUCTR) | 05/04/2012 | 05/03/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan | ||
| 21 | NCT01545076 (ClinicalTrials.gov) | March 2012 | 1/3/2012 | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20) | Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Phase III Study to Investigate the Efficacy, Safety, and Tolerability of 2 Different Doses of IgPro20 (Subcutaneous Immunoglobulin) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - the PATH Study | Chronic Inflammatory Demyelinating Polyneuropathy;Polyradiculoneuropathy | Biological: IgPro20 (low dose);Biological: Placebo;Biological: IgPro10;Biological: IgPro20 (high dose) | CSL Behring | ICON Clinical Research | Completed | 18 Years | N/A | All | 208 | Phase 3 | United States;Australia;Belgium;Canada;Czechia;Estonia;Finland;France;Germany;Israel;Italy;Japan;Netherlands;Poland;Spain;United Kingdom;Austria;Czech Republic |
50. 皮膚筋炎／多発性筋炎
臨床試験数 : 194 / 薬物数 : 244 - (DrugBank : 89) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 151
| 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 | EUCTR2018-003171-35-HU (EUCTR) | 13/02/2023 | 14/12/2022 | A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM) | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) – The RECLAIIM Study | Dermatomyositis MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Hizentra Product Name: human immunoglobulin G Product Code: IgPro20 INN or Proposed INN: human immunoglobulin G Other descriptive name: Hizentra | CSL Behring LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 126 | Phase 3 | Argentina;Russian Federation;Hungary;United States;Japan;Ukraine;United Kingdom;Switzerland;Spain;Belgium;European Union;Mexico;Italy;Australia;France;Germany | ||
| 2 | EUCTR2018-003171-35-DE (EUCTR) | 20/01/2020 | 18/09/2019 | A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM) | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) – The RECLAIIM Study | Dermatomyositis MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Hizentra Product Name: human immunoglobulin G Product Code: IgPro20 INN or Proposed INN: human immunoglobulin G Other descriptive name: Hizentra | CSL Behring LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 126 | Phase 3 | United States;Spain;Ukraine;Russian Federation;Italy;Switzerland;United Kingdom;France;Mexico;European Union;Argentina;Belgium;Australia;Germany;Japan | ||
| 3 | EUCTR2018-003171-35-BE (EUCTR) | 21/11/2019 | 18/09/2019 | A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM) | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) – The RECLAIIM Study | Dermatomyositis MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Hizentra Product Name: human immunoglobulin G Product Code: IgPro20 INN or Proposed INN: human immunoglobulin G Other descriptive name: Hizentra | CSL Behring LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 126 | Phase 3 | United States;Spain;Ukraine;Russian Federation;Italy;Switzerland;United Kingdom;France;Mexico;European Union;Argentina;Belgium;Australia;Germany;Japan | ||
| 4 | EUCTR2018-003171-35-ES (EUCTR) | 14/11/2019 | 29/11/2019 | A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM) | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) | Dermatomyositis MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Hizentra Product Name: human immunoglobulin G Product Code: IgPro20 INN or Proposed INN: human immunoglobulin G Other descriptive name: Hizentra | CSL Behring LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 126 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ukraine;Russian Federation;Switzerland;United Kingdom;France;European Union;Mexico;Canada;Argentina;Australia;Germany;Japan | ||
| 5 | EUCTR2018-003171-35-IT (EUCTR) | 21/10/2019 | 22/01/2021 | A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM) | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) - NA | Dermatomyositis MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Hizentra Product Name: human immunoglobulin G Product Code: [IgPro20] INN or Proposed INN: human immunoglobulin G Other descriptive name: Hizentra | CSL BEHRING GMBH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 126 | Phase 3 | United States;Spain;Ukraine;Russian Federation;Italy;Switzerland;United Kingdom;France;Mexico;European Union;Canada;Argentina;Australia;Germany;Japan | ||
| 6 | NCT04044690 (ClinicalTrials.gov) | October 21, 2019 | 1/8/2019 | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM) | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults With Dermatomyositis (DM) - The RECLAIIM Study | Dermatomyositis | Drug: human immunoglobulin G;Drug: Placebo | CSL Behring | NULL | Recruiting | 18 Years | N/A | All | 126 | Phase 3 | United States;Belgium;Czechia;France;Germany;Italy;Japan;Mexico;Netherlands;Poland;Russian Federation;Spain;Switzerland;Ukraine;United Kingdom;Australia |
| 7 | EUCTR2018-003171-35-FR (EUCTR) | 24/09/2019 | 11/09/2019 | A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM) | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) | Dermatomyositis MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Hizentra Product Name: human immunoglobulin G Product Code: IgPro20 INN or Proposed INN: human immunoglobulin G Other descriptive name: Hizentra | CSL Behring LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 126 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;France;Mexico;European Union;Canada;Argentina;Ukraine;Australia;Russian Federation;Japan;United Kingdom;Switzerland |
51. 全身性強皮症
臨床試験数 : 525 / 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 217
| 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 | EUCTR2018-003149-41-DE (EUCTR) | 16/07/2019 | 20/03/2019 | Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults with Systemic Sclerosis (SSc). | A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in Adults with Systemic Sclerosis (SSc). - n/a | Safety and Pharmacokinetics in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Hizentra Product Name: Human normal immunoglobulin for subcutaneous administration Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 26 | Phase 2 | France;Poland;Australia;Germany;United Kingdom;Italy | ||
| 2 | EUCTR2018-003149-41-FR (EUCTR) | 24/05/2019 | 27/03/2019 | Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults with Systemic Sclerosis (SSc). | A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in Adults with Systemic Sclerosis (SSc). - n/a | Safety and Pharmacokinetics in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Hizentra Product Name: Human normal immunoglobulin for subcutaneous administration Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 26 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Poland;Australia;Germany;Italy;United Kingdom | ||
| 3 | EUCTR2018-003149-41-IT (EUCTR) | 23/05/2019 | 22/01/2021 | Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults with Systemic Sclerosis (SSc). | A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in Adults with Systemic Sclerosis (SSc). - NA | Safety and Pharmacokinetics in subjects with diffuse cutaneous systemicsclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Hizentra Product Name: Immunoglobulina Normale Umana per somministrazione sottocutanea Product Code: [IgPro20] INN or Proposed INN: IMMUNOGLOBULINA UMANA NORMALE Trade Name: Privigen Product Name: immunoglobulina Normale Umana per somministrazione endovenosa Product Code: [IgPro10] INN or Proposed INN: immunoglobulina normale umana | CSL BEHRING GMBH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 26 | Phase 2 | France;Poland;Australia;Germany;United Kingdom;Italy | ||
| 4 | EUCTR2018-003149-41-GB (EUCTR) | 15/05/2019 | 30/07/2019 | Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults with Systemic Sclerosis (SSc). | A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in Adults with Systemic Sclerosis (SSc). - n/a | Safety and Pharmacokinetics in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Hizentra Product Name: Human normal immunoglobulin for subcutaneous administration Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 26 | Phase 2 | France;Poland;Australia;Germany;Italy;United Kingdom |
65. 原発性免疫不全症候群
臨床試験数 : 500 / 薬物数 : 614 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 217
| 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 | NCT03033745 (ClinicalTrials.gov) | February 1, 2017 | 23/1/2017 | Safety and Tolerability of Higher Infusion Parameters of IgPro20 (Hizentra) in Subjects With Primary Immunodeficiency (PID) | An Open-label Multicenter Study to Evaluate the Safety and Tolerability of Higher Infusion Parameters of Immune Globulin Subcutaneous (Human), 20% Liquid (Hizentra®) in Subjects With Primary Immunodeficiency | Primary Immunodeficiency | Drug: IgPro20 | CSL Behring | NULL | Completed | 2 Years | N/A | All | 49 | Phase 4 | United States;Canada |
| 2 | NCT01461018 (ClinicalTrials.gov) | October 2011 | 24/10/2011 | Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study) | A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) IgPro20 in Subjects With Primary Immunodeficiency | Primary Immune Deficiency | Biological: Immune globulin subcutaneous (Human) | CSL Behring | NULL | Completed | N/A | 75 Years | Both | 22 | Phase 3 | Japan |
| 3 | NCT01458171 (ClinicalTrials.gov) | April 2011 | 12/10/2011 | Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study) | A Multicenter Follow-up Study of Long-term Safety, Tolerability, and Efficacy of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency | Primary Immune Deficiency Disorder | Biological: Immune globulin subcutaneous (Human) | CSL Behring | NULL | Completed | N/A | 75 Years | All | 23 | Phase 3 | Japan |
| 4 | NCT01199705 (ClinicalTrials.gov) | September 2010 | 8/9/2010 | Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study) | A Multicenter Study of Efficacy, Safety, Tolerability, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency | Primary Immune Deficiency | Biological: Immune Globulin Subcutaneous (Human) (SCIG) | CSL Behring | NULL | Completed | N/A | 75 Years | All | 25 | Phase 3 | Japan |
| 5 | EUCTR2008-000830-30-SE (EUCTR) | 17/12/2008 | 03/11/2008 | A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency(IgPro20 EU Extension Study) | A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency(IgPro20 EU Extension Study) | PID (primary immunodeficiency) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome | Product Name: IgPro20 Product Code: IgPro20 INN or Proposed INN: normal human immunoglobulin G | CSL Behring AG | NULL | Not Recruiting | Female: yes Male: yes | 36 | United Kingdom;Germany;France;Spain;Sweden | |||
| 6 | EUCTR2008-000830-30-GB (EUCTR) | 10/12/2008 | 20/01/2009 | Extension study designed to test the long-term safety and effectiveness of Immunoglobulin Subcutaneous (Human), IgPro20. | A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency (IgPro20 EU Extension Study) | PID (Primary Immune Deficiency) MedDRA version: 13.1;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human Normal Immunoglobulin | CSL Behring AG | NULL | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Spain;Poland;Romania;Germany;Switzerland;United Kingdom;Sweden | ||
| 7 | EUCTR2008-000830-30-FR (EUCTR) | 24/11/2008 | 21/10/2008 | A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency(IgPro20 EU Extension Study) | A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency(IgPro20 EU Extension Study) | PID (primary immunodeficiency) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome | Product Name: IgPro20 Product Code: IgPro20 INN or Proposed INN: Human Normal Immunoglobulin | CSL Behring AG | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 3 | France;Spain;Germany;United Kingdom;Sweden | ||
| 8 | EUCTR2008-000830-30-ES (EUCTR) | 12/11/2008 | 01/10/2008 | A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of ImmuneGlobulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency(IgPro20 EU Extension Study)Un estudio de extensión multicéntrico sobre la eficacia, tolerabilidad y seguridad de la inmunoglobulina subcutánea (humana) IgPro20 en pacientes con inmunodeficiencia primaria(Estudio de extensión de la UE sobre IgPro20) | A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of ImmuneGlobulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency(IgPro20 EU Extension Study)Un estudio de extensión multicéntrico sobre la eficacia, tolerabilidad y seguridad de la inmunoglobulina subcutánea (humana) IgPro20 en pacientes con inmunodeficiencia primaria(Estudio de extensión de la UE sobre IgPro20) | Primary Immunodeficiency (PID)inmunodeficiencia primaria (IDP) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome | Product Name: IgPro20 Product Code: IgPro20 INN or Proposed INN: Human Normal Immunoglobulin | CSL Behring AG | NULL | Not Recruiting | Female: yes Male: yes | 36 | United Kingdom;Germany;France;Spain;Sweden | |||
| 9 | EUCTR2006-006745-13-PL (EUCTR) | 16/10/2008 | 11/08/2008 | A multicenter study of the efficacy, tolerability, safety, and pharmacokinetics of Immune Globuline Subcutaneous (Human) IgPro20 in subjects with Primary Immunodeficiency (PID) | A multicenter study of the efficacy, tolerability, safety, and pharmacokinetics of Immune Globuline Subcutaneous (Human) IgPro20 in subjects with Primary Immunodeficiency (PID) | PID (Primary Immunodeficiency) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome | Product Name: IgPro20 Other descriptive name: IMMUNOGLOBULIN G | CSL Behring | NULL | Not Recruiting | Female: yes Male: yes | 43 | Phase 3 | France;Spain;Poland;Germany;Italy;United Kingdom;Sweden | ||
| 10 | NCT00751621 (ClinicalTrials.gov) | August 2008 | 11/9/2008 | Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (EU Extension Study) | A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency (IgPro20 EU Extension Study) | Primary Immunodeficiency (PID) | Biological: IgPro20 | CSL Behring | NULL | Completed | 2 Years | 65 Years | All | 40 | Phase 3 | France;Germany;Poland;Romania;Spain;Sweden;Switzerland;United Kingdom |
| 11 | EUCTR2008-000830-30-DE (EUCTR) | 10/07/2008 | 09/06/2008 | A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency(IgPro20 EU Extension Study) | A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency(IgPro20 EU Extension Study) | PID (primary immuno deficiency) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome | Product Name: IgPro20 Product Code: IgPro20 INN or Proposed INN: Human Normal Immunoglobulin | CSL Behring AG | NULL | Not Recruiting | Female: yes Male: yes | 36 | United Kingdom;Germany;France;Spain;Sweden | |||
| 12 | NCT00719680 (ClinicalTrials.gov) | June 2008 | 21/7/2008 | Extension Study of Subcutaneous Immunoglobulin Human in Patients With Primary Immunodeficiency (PID) | A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency (PID) | Primary Immune Deficiency | Biological: IgPro20 | CSL Behring | NULL | Completed | 2 Years | 75 Years | All | 21 | Phase 3 | United States |
| 13 | EUCTR2006-006745-13-SE (EUCTR) | 19/09/2007 | 23/07/2007 | A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency | A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency | PID (Primary Immunodeficiency) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome | Product Name: IgPro20 Product Code: IgPro20 INN or Proposed INN: Human Immunglobulin G (IgG) | CSL Behring AG | NULL | Not Recruiting | Female: yes Male: yes | 51 | United Kingdom;Germany;France;Spain;Italy;Poland;Sweden | |||
| 14 | NCT00542997 (ClinicalTrials.gov) | September 2007 | 11/10/2007 | Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy | A Multicentre Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency | Common Variable Immunodeficiency;X-linked Agammaglobulinemia;Autosomal Recessive Agammaglobulinemia | Biological: Human Normal Immunoglobulin for Subcutaneous Administration (IGSC) | CSL Behring | NULL | Completed | 2 Years | 65 Years | All | 51 | Phase 3 | France;Germany;Italy;Poland;Romania;Spain;Sweden;Switzerland;United Kingdom |
| 15 | EUCTR2006-006745-13-IT (EUCTR) | 30/08/2007 | 01/08/2007 | A Multicenter Study of the Efficacy, Tolerability, Safety and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency - ND | A Multicenter Study of the Efficacy, Tolerability, Safety and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency - ND | PID (Primary Immunodeficiency) MedDRA version: 6.1;Level: HLGT;Classification code 10021460 | Product Name: IgPro20 Product Code: IgPro20 INN or Proposed INN: Immunoglobulins, normal human | CSL Behring AG (casa madre) | NULL | Not Recruiting | Female: yes Male: yes | 36 | United Kingdom;Germany;France;Spain;Italy;Poland;Sweden | |||
| 16 | EUCTR2006-006745-13-ES (EUCTR) | 27/08/2007 | 11/06/2007 | Estudio multicéntrico sobre la eficacia, la tolerabilidad, la seguridad y la farmacocinética de la immunoglobulina subcutánea (humana) IgPro20 en sujetos con immunodeficiencia orimaria (PID)A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency | Estudio multicéntrico sobre la eficacia, la tolerabilidad, la seguridad y la farmacocinética de la immunoglobulina subcutánea (humana) IgPro20 en sujetos con immunodeficiencia orimaria (PID)A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency | immunodeficencia primaria (PID) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome | Product Name: IgPro20 Product Code: IgPro20 INN or Proposed INN: Human Immunglobulin G (IgG) | CSL Behring AG | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 3 | France;Poland;Spain;Germany;Italy;United Kingdom;Sweden | ||
| 17 | EUCTR2006-006745-13-GB (EUCTR) | 17/07/2007 | 15/05/2007 | A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency | A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency | PID (Primary Immunodeficiency) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome | Product Name: IgPro20 Product Code: IgPro20 INN or Proposed INN: Human Immunglobulin G (IgG) | CSL Behring AG | NULL | Not Recruiting | Female: yes Male: yes | 51 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Poland;Spain;Germany;Italy;United Kingdom;Sweden | ||
| 18 | EUCTR2006-006745-13-DE (EUCTR) | 11/07/2007 | 21/03/2007 | A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency | A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency | PID (Primary Immunodeficiency) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome | Product Name: IgPro20 Product Code: IgPro20 INN or Proposed INN: Human Immunglobulin G (IgG) | CSL Behring AG | NULL | Not Recruiting | Female: yes Male: yes | 51 | United Kingdom;Germany;France;Spain;Italy;Poland;Sweden | |||
| 19 | EUCTR2006-006745-13-FR (EUCTR) | 10/07/2007 | 04/06/2007 | A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency | A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency | PID (Primary Immunodeficiency) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome | Product Name: IgPro20 Product Code: IgPro20 INN or Proposed INN: Human Immunglobulin G (IgG) | CSL Behring AG | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 3 | France;Poland;Spain;Germany;Italy;United Kingdom;Sweden | ||
| 20 | NCT00419341 (ClinicalTrials.gov) | November 2006 | 22/12/2006 | Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy | A Phase III Open-Label, Prospective, Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human), IgPro20 in Subjects With Primary Immunodeficiency (PID) | Primary Immune Deficiency | Biological: Human Normal Immunoglobulin for Subcutaneous Administration | CSL Behring | NULL | Completed | 2 Years | 75 Years | All | 49 | Phase 3 | United States |
| 21 | EUCTR2014-003609-14-Outside-EU/EEA (EUCTR) | 05/01/2015 | Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study) | A Multicenter Follow-up Study of Long-term Safety, Tolerability, and Efficacy of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency | Primary Immune Deficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Hizentra® INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring | NULL | NA | Female: yes Male: yes | 23 | Japan | ||||
| 22 | EUCTR2014-003608-61-Outside-EU/EEA (EUCTR) | 05/01/2015 | Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study) | A Multicenter Study of Efficacy, Safety, Tolerability, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency | Primary Immune Deficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Hizentra® INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring | NULL | NA | Female: yes Male: yes | 25 | Japan | ||||
| 23 | EUCTR2014-003607-30-Outside-EU/EEA (EUCTR) | 26/02/2015 | Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy | A Phase III Open-Label, Prospective, Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human), IgPro20 in Subjects With Primary Immunodeficiency (PID) | Primary Immune Deficiency MedDRA version: 17.1;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Hizentra® Product Name: IgPro20 Product Code: IgPro20 INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring AG | NULL | NA | Female: yes Male: yes | 49 | Phase 3 | United States | |||
| 24 | EUCTR2016-003799-33-Outside-EU/EEA (EUCTR) | 30/01/2017 | Safety and tolerability of higher infusion parameters of IgPro20 (Hizentra) in subjects with primary immunodeficiency (PID) | An open-label multicenter study to evaluate the safety and tolerability of higher infusion parameters of immune globulin subcutaneous (human), 20% liquid (Hizentra®) in subjects with primary immunodeficiency | Primary immunodeficiency MedDRA version: 19.1;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Hizentra Product Name: Hizentra; human normal immunoglobulin (subcutaneous) Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring LLC | NULL | NA | Female: yes Male: yes | 51 | Phase 4 | United States;Canada | |||
| 25 | EUCTR2014-003605-15-Outside-EU/EEA (EUCTR) | 26/02/2015 | Extension Study of Subcutaneous Immunoglobulin Human in Patients With Primary Immunodeficiency (PID) | A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency (PID) | Primary Immune Deficiency (PID) MedDRA version: 17.1;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Hizentra® INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring AG | NULL | NA | Female: yes Male: yes | 21 | United States | ||||
| 26 | EUCTR2014-003409-13-Outside-EU/EEA (EUCTR) | 05/01/2015 | Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects with Primary Immunodeficiency (Japan Study) | A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) IgPro20 in Subjects with Primary Immunodeficiency | Primary Immune Deficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Hizentra® INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: Human Normal Immunoglobulin | CSL Behring | NULL | NA | Female: yes Male: yes | 22 | Japan |