11. 重症筋無力症 Myasthenia gravis Clinical trials / Disease details
臨床試験数 : 332 / 薬物数 : 234 - (DrugBank : 81) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 127
| 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 | EUCTR2014-003997-18-DE (EUCTR) | 30/05/2016 | 27/07/2015 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21). | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 62 | Phase 2 | Lithuania;Germany;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;France;United States | ||
| 2 | EUCTR2013-005098-28-LV (EUCTR) | 17/12/2015 | 22/10/2015 | A study investigating Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis exacerbations. All patients will receive a single dose course of IGIV-C treatment followed by 28-days of post-infusion assessments. | A multicenter, prospective, open-label, non-controlled clinical trial to assess the efficacy and safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in patients with Myasthenia Gravis exacerbations | Myasthenia Gravis Exacerbations MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics LLC | NULL | Not Recruiting | Female: yes Male: yes | 50 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Hungary;Estonia;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;South Africa;Latvia | ||
| 3 | EUCTR2013-005099-17-DE (EUCTR) | 18/11/2015 | 28/07/2015 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose. | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany | ||
| 4 | EUCTR2013-005098-28-EE (EUCTR) | 07/10/2015 | 14/09/2015 | A study investigating Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis exacerbations. All patients will receive a single dose course of IGIV-C treatment followed by 28-days of post-infusion assessments. | A multicenter, prospective, open-label, non-controlled clinical trial to assess the efficacy and safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in patients with Myasthenia Gravis exacerbations | Myasthenia Gravis Exacerbations MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics LLC | NULL | Not Recruiting | Female: yes Male: yes | 50 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Hungary;Czech Republic;Estonia;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;South Africa;Latvia | ||
| 5 | EUCTR2013-005099-17-BE (EUCTR) | 06/10/2015 | 15/01/2016 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose. | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 19.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany | ||
| 6 | EUCTR2014-003997-18-BE (EUCTR) | 06/10/2015 | 18/01/2016 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21). | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 18.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 62 | Phase 2 | France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany | ||
| 7 | EUCTR2013-005099-17-CZ (EUCTR) | 10/09/2015 | 17/06/2015 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose. | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Hungary;Estonia;Czech Republic;Canada;Belgium;Poland;Lithuania;Germany | ||
| 8 | EUCTR2014-003997-18-CZ (EUCTR) | 10/09/2015 | 17/06/2015 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21). | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 62 | Phase 2 | France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany | ||
| 9 | NCT02473952 (ClinicalTrials.gov) | August 2015 | 14/6/2015 | A Study to Evaluate the Efficacy and Safety of IGIV-C in Symptomatic Subjects With Generalized Myasthenia Gravis | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in Symptomatic Subjects With Generalized Myasthenia Gravis | Myasthenia Gravis, Generalized | Drug: IGIV-C;Drug: Placebo | Grifols Therapeutics LLC | NULL | Completed | 18 Years | 85 Years | All | 62 | Phase 2 | United States;Belgium;Canada;Czechia;Estonia;France;Germany;Hungary;Lithuania;Poland;Czech Republic |
| 10 | EUCTR2013-005098-28-RO (EUCTR) | 21/07/2015 | 10/03/2015 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis exacerbations. All patients will receive a single dose course of IGIV-C treatment followed by 28-days of post-infusion assessments. | A multicenter, prospective, open-label, non-controlled clinical trial to assess the efficacy and safety of Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in patients with Myasthenia Gravis exacerbations | Myasthenia Gravis Exacerbations MedDRA version: 18.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | France;Estonia;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Russian Federation;Latvia;Germany | ||
| 11 | EUCTR2013-005099-17-HU (EUCTR) | 13/07/2015 | 26/05/2015 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose. | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 18.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Estonia;Czech Republic;Hungary;Canada;Poland;Belgium;Lithuania;Germany | ||
| 12 | EUCTR2014-003997-18-HU (EUCTR) | 13/07/2015 | 26/05/2015 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21). | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 18.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 62 | Phase 2 | France;United States;Estonia;Czech Republic;Hungary;Canada;Poland;Belgium;Lithuania;Germany | ||
| 13 | EUCTR2013-005099-17-LT (EUCTR) | 07/07/2015 | 25/05/2015 | A study investigating Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose. | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Canada;Czech Republic;Belgium;Hungary;United States;Poland;Lithuania;France;Germany;Estonia | ||
| 14 | EUCTR2013-005098-28-PL (EUCTR) | 07/07/2015 | 01/06/2015 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis exacerbations. All patients will receive a single dose course of IGIV-C treatment followed by 28-days of post-infusion assessments. | A multicenter, prospective, open-label, non-controlled clinical trial to assess the efficacy and safety of Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in patients with Myasthenia Gravis exacerbations | Myasthenia Gravis Exacerbations MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | France;Hungary;Estonia;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Russian Federation;South Africa;Latvia | ||
| 15 | EUCTR2014-003997-18-LT (EUCTR) | 07/07/2015 | 25/05/2015 | A study investigating Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21). | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 62 | Phase 2 | France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany | ||
| 16 | EUCTR2014-003997-18-EE (EUCTR) | 22/06/2015 | 26/05/2015 | A study investigating Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21). | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 62 | Phase 2 | France;United States;Hungary;Czech Republic;Estonia;Canada;Poland;Belgium;Lithuania;Germany | ||
| 17 | EUCTR2013-005099-17-EE (EUCTR) | 22/06/2015 | 26/05/2015 | A study investigating Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose. | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics LLC | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Hungary;Czech Republic;Estonia;Canada;Poland;Belgium;Lithuania;Germany | ||
| 18 | NCT02473965 (ClinicalTrials.gov) | June 2015 | 14/6/2015 | Efficacy and Safety of IGIV-C in Corticosteroid Dependent Patients With Generalized Myasthenia Gravis | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of lGIV-C as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients With Generalized Myasthenia Gravis | Myasthenia Gravis | Drug: IGIV-C;Drug: Placebo | Grifols Therapeutics LLC | NULL | Completed | 18 Years | 85 Years | All | 60 | Phase 2 | United States;Belgium;Canada;Czechia;Estonia;France;Germany;Hungary;Lithuania;Poland;Czech Republic |
| 19 | EUCTR2013-005098-28-BE (EUCTR) | 13/03/2015 | 12/12/2014 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis exacerbations. All patients will receive a single dose course of IGIV-C treatment followed by 28-days of post-infusion assessments. | A multicenter, prospective, open-label, non-controlled clinical trial to assess the efficacy and safety of Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in patients with Myasthenia Gravis exacerbations | Myasthenia Gravis Exacerbations MedDRA version: 18.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | Estonia;Russian Federation;Israel;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;South Africa;Latvia;Germany;Netherlands;Korea, Republic of | ||
| 20 | NCT02413580 (ClinicalTrials.gov) | March 2015 | 7/4/2015 | A Study to Assess the Efficacy and Safety of IGIV-C in Patients With Myasthenia Gravis Exacerbations | A Multicenter, Prospective, Open-label, Non-controlled Clinical Trial to Assess the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in Patients With Myasthenia Gravis Exacerbations | Myasthenia Gravis Exacerbations | Biological: IGIV-C | Grifols Therapeutics LLC | NULL | Completed | 18 Years | N/A | All | 49 | Phase 3 | Argentina;Belgium;Canada;Czechia;Estonia;France;Hungary;Latvia;Poland;Romania;Russian Federation;South Africa;Czech Republic |
| 21 | EUCTR2013-005098-28-CZ (EUCTR) | 16/01/2015 | 03/10/2014 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis exacerbations. All patients will receive a single dose course of IGIV-C treatment followed by 28-days of post-infusion assessments. | A multicenter, prospective, open-label, non-controlled clinical trial to assess the efficacy and safety of Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in patients with Myasthenia Gravis exacerbations | Myasthenia Gravis Exacerbations MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics LLC. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | France;Hungary;Estonia;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;South Africa;Latvia | ||
| 22 | EUCTR2013-005098-28-HU (EUCTR) | 21/11/2014 | 07/10/2014 | A multicenter, prospective, open-label, non-controlled clinical trial to assess the efficacy and safety of Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in patients with Myasthenia Gravis exacerbations | A multicenter, prospective, open-label, non-controlled clinical trial to assess the efficacy and safety of Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in patients with Myasthenia Gravis exacerbations | Myasthenia Gravis Exacerbations MedDRA version: 19.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | Estonia;Russian Federation;France;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;South Africa;Netherlands;Latvia |