Octagam 10% (DrugBank: -)
3 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 50 | 皮膚筋炎／多発性筋炎 | 5 |
| 63 | 特発性血小板減少性紫斑病 | 6 |
| 65 | 原発性免疫不全症候群 | 3 |
| 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 | EUCTR2016-002902-37-NL (EUCTR) | 28/06/2018 | 24/01/2018 | CLINICAL TRIAL TO EVALUATE EFFICACY AND SAFETY OF OCTAGAM 10% IN PATIENTS WITH DERMATOMYOSITIS (ProDERM Study) | PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF OCTAGAM 10% IN PATIENTS WITH DERMATOMYOSITIS - (ProDERM Study) | Dermatomyositis MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Octapharma Pharmazeutika Produktionsges.m.b.H. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 94 | Phase 3 | France;United States;Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Russian Federation;Germany;Netherlands | |||
| 2 | NCT02728752 (ClinicalTrials.gov) | February 27, 2017 | 11/3/2016 | Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy) | Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (ProDERM Study) | Dermatomyositis | Drug: Octagam 10%;Other: Placebo | Octapharma | NULL | Completed | 18 Years | N/A | All | 95 | Phase 3 | United States;Canada;Czechia;Germany;Hungary;Netherlands;Poland;Romania;Russian Federation;Ukraine;Czech Republic;France |
| 3 | EUCTR2016-002902-37-DE (EUCTR) | 21/02/2017 | 29/09/2016 | CLINICAL TRIAL TO EVALUATE EFFICACY AND SAFETY OF OCTAGAM 10% IN PATIENTS WITH DERMATOMYOSITIS (ProDERM Study) | PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF OCTAGAM 10% IN PATIENTS WITH DERMATOMYOSITIS - (ProDERM Study) | Dermatomyositis MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Octapharma Pharmazeutika Produktionsges.m.b.H. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 94 | Phase 3 | France;United States;Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Russian Federation;Netherlands;Germany | |||
| 4 | EUCTR2016-002902-37-HU (EUCTR) | 09/02/2017 | 19/12/2016 | CLINICAL TRIAL TO EVALUATE EFFICACY AND SAFETY OF OCTAGAM 10% IN PATIENTS WITH DERMATOMYOSITIS (ProDERM Study) | PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF OCTAGAM 10% IN PATIENTS WITH DERMATOMYOSITIS - (ProDERM Study) | Dermatomyositis MedDRA version: 19.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Octagam 10% INN or Proposed INN: IMMUNOGLOBULIN G Trade Name: Octagam 10% INN or Proposed INN: IMMUNOGLOBULIN G Trade Name: Octagam 10% INN or Proposed INN: IMMUNOGLOBULIN G | Octapharma Pharmazeutika Produktionsges.m.b.H. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 94 | Phase 3 | France;United States;Czech Republic;Hungary;Canada;Poland;Russian Federation;Germany | ||
| 5 | EUCTR2016-002902-37-CZ (EUCTR) | 20/12/2016 | 26/09/2016 | CLINICAL TRIAL TO EVALUATE EFFICACY AND SAFETY OF OCTAGAM 10% IN PATIENTS WITH DERMATOMYOSITIS (ProDERM Study) | PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF OCTAGAM 10% IN PATIENTS WITH DERMATOMYOSITIS - (ProDERM Study) | Dermatomyositis MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Octapharma Pharmazeutika Produktionsges.m.b.H. | NULL | Not Recruiting | Female: yes Male: yes | 94 | Phase 3 | France;United States;Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Russian Federation;Netherlands;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 | EUCTR2012-000796-16-PL (EUCTR) | 17/08/2012 | 25/06/2012 | Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune thrombocytopenia | PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA | Primary Immune Thrombocytopenia (ITP) MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Octagam 10% Product Name: Octagam 10% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | Czech Republic;Poland;Bulgaria | ||
| 2 | EUCTR2012-000796-16-BG (EUCTR) | 18/07/2012 | 22/05/2012 | Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune thrombocytopenia | PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA | Primary Immune Thrombocytopenia (ITP) MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Octagam 10% Product Name: Octagam 10% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | Czech Republic;Poland;Bulgaria | ||
| 3 | EUCTR2012-000796-16-DE (EUCTR) | 09/07/2012 | 20/03/2012 | Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune thrombocytopenia | PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA | Primary Immune Thrombocytopenia (ITP) MedDRA version: 14.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Octagam 10% Product Name: Octagam 10% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | Germany;Czech Republic;Poland;Bulgaria | ||
| 4 | EUCTR2012-000796-16-CZ (EUCTR) | 29/05/2012 | 04/04/2012 | Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune thrombocytopenia | PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA | Primary Immune Thrombocytopenia (ITP) MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Octagam 10% Product Name: Octagam 10% INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: IMMUNOGLOBULIN G | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | Czech Republic;Poland;Bulgaria;Germany | ||
| 5 | NCT00426270 (ClinicalTrials.gov) | June 2006 | 22/1/2007 | Clinical Study to Evaluate the Efficacy and Safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura in Adults | Clinical Study to Evaluate the Efficacy and Safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in Adults | Immune Thrombocytopenic Purpura | Drug: Octagam 10% | Octapharma | NULL | Completed | 18 Years | N/A | All | 116 | Phase 3 | Austria |
| 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 | EUCTR2005-003552-35-CZ (EUCTR) | 13/03/2006 | 23/01/2006 | Clinical study to evaluate the efficacy and safety of Octagam(R) 10% in Idiopathic Thrombocytopenic Purpura in adults - NA | Clinical study to evaluate the efficacy and safety of Octagam(R) 10% in Idiopathic Thrombocytopenic Purpura in adults - NA | Idiopathic Thrombocytopenic Purpura in adults actively bleeding or at high risk of bleeding MedDRA version: 7.0;Level: LLT;Classification code 10021245 | Product Name: Octagam 10% | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 116 | Germany;Czech Republic;France |
| 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 | EUCTR2007-002611-27-FR (EUCTR) | 17/02/2010 | 26/11/2009 | Clinical study to evaluate the efficacy, safety and kinetics of Octagam® 10% for replacement therapy in Primary Immunodeficiency Diseases (PID) - NA | Clinical study to evaluate the efficacy, safety and kinetics of Octagam® 10% for replacement therapy in Primary Immunodeficiency Diseases (PID) - NA | Primary Immunodeficiency Diseases (PID) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome | Trade Name: Octagam 10% Product Name: Octagam 10% INN or Proposed INN: Human Normal Immunoglobulin | Octapharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | United Kingdom;France | |||
| 2 | NCT00811174 (ClinicalTrials.gov) | January 2009 | 17/12/2008 | Efficacy, Safety and Kinetics Study of Octagam 10% in Primary Immunodeficiency Diseases | Clinical Study to Evaluate the Efficacy, Safety and Kinetics of Octagam 10% for Replacement Therapy in Primary Immunodeficiency Diseases | Immunologic Deficiency Syndromes | Drug: Octagam 10% | Octapharma | NULL | Terminated | 2 Years | 75 Years | All | 5 | Phase 3 | Austria |
| 3 | EUCTR2007-002611-27-DE (EUCTR) | 27/10/2008 | 14/12/2007 | Clinical study to evaluate the efficacy, safety and kinetics of Octagam® 10% for replacement therapy in Primary Immunodeficiency Diseases (PID) - NA | Clinical study to evaluate the efficacy, safety and kinetics of Octagam® 10% for replacement therapy in Primary Immunodeficiency Diseases (PID) - NA | Primary Immundeficiency Diseases (PID) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome | Trade Name: Octagam 10% Product Name: Octagam 10% | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 45 | France;Germany;United Kingdom |