11. 重症筋無力症 [臨床試験数:226,薬物数:172(DrugBank:45),標的遺伝子数:43,標的パスウェイ数:118

Searched query = "Myasthenia", "MG"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
23 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-003997-18-DE30/05/201627/07/2015A 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: 20.0Level: PTClassification code 10028417Term: Myasthenia gravisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
62Phase 2Lithuania;Germany;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;France;United States
2EUCTR2013-005098-28-LV17/12/201522/10/2015A 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]
Grifols Therapeutics LLCNULLNot Recruiting Female: yes
Male: yes
50 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;Hungary;Estonia;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;South Africa;Latvia
3EUCTR2013-005099-17-DE18/11/201528/07/2015A 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]
Grifols Therapeutics Inc.NULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany
4EUCTR2013-005098-28-EE07/10/201514/09/2015A 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]
Grifols Therapeutics LLCNULLNot Recruiting Female: yes
Male: yes
50 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;Hungary;Czech Republic;Estonia;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;South Africa;Latvia
5EUCTR2014-003997-18-BE06/10/201518/01/2016A 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: 18.1Level: PTClassification code 10028417Term: Myasthenia gravisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
62Phase 2France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2013-005099-17-BE06/10/201515/01/2016A 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: 19.1Level: PTClassification code 10028417Term: Myasthenia gravisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany
7EUCTR2013-005099-17-CZ10/09/201517/06/2015A 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]
Grifols Therapeutics Inc.NULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;United States;Hungary;Estonia;Czech Republic;Canada;Belgium;Poland;Lithuania;Germany
8EUCTR2014-003997-18-CZ10/09/201517/06/2015A 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: 20.0Level: PTClassification code 10028417Term: Myasthenia gravisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
62Phase 2France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany
9NCT02473952August 201514/6/2015A Study to Evaluate the Efficacy and Safety of IGIV-C in Symptomatic Subjects With Generalized Myasthenia GravisA 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 GravisMyasthenia Gravis, GeneralizedDrug: IGIV-C;Drug: PlaceboGrifols Therapeutics LLCNULLCompleted18 Years85 YearsAll62Phase 2United States;Belgium;Canada;Czechia;Estonia;France;Germany;Hungary;Lithuania;Poland;Czech Republic
10EUCTR2013-005098-28-RO21/07/201510/03/2015A 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: 18.1Level: PTClassification code 10028417Term: Myasthenia gravisSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50France;Estonia;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Russian Federation;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2014-003997-18-HU13/07/201526/05/2015A 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: 18.1Level: PTClassification code 10028417Term: Myasthenia gravisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
62Phase 2France;United States;Estonia;Czech Republic;Hungary;Canada;Poland;Belgium;Lithuania;Germany
12EUCTR2013-005099-17-HU13/07/201526/05/2015A 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]
Grifols Therapeutics Inc.NULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;United States;Estonia;Czech Republic;Hungary;Canada;Poland;Belgium;Lithuania;Germany
13EUCTR2013-005098-28-PL07/07/201501/06/2015A 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: 20.0Level: PTClassification code 10028417Term: Myasthenia gravisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3France;Hungary;Estonia;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Russian Federation;South Africa;Latvia
14EUCTR2013-005099-17-LT07/07/201525/05/2015A 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: 20.0Level: PTClassification code 10028417Term: Myasthenia gravisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany
15EUCTR2014-003997-18-LT07/07/201525/05/2015A 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: 20.0Level: PTClassification code 10028417Term: Myasthenia gravisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
62Phase 2France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2013-005099-17-EE22/06/201526/05/2015A 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]
Grifols Therapeutics LLCNULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;United States;Hungary;Czech Republic;Estonia;Canada;Poland;Belgium;Lithuania;Germany
17EUCTR2014-003997-18-EE22/06/201526/05/2015A 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: 20.0Level: PTClassification code 10028417Term: Myasthenia gravisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
62Phase 2France;United States;Hungary;Czech Republic;Estonia;Canada;Poland;Belgium;Lithuania;Germany
18EUCTR2013-005098-28-BE13/03/201512/12/2014A 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: 18.1Level: PTClassification code 10028417Term: Myasthenia gravisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3Estonia;Russian Federation;Israel;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;South Africa;Latvia;Germany;Netherlands;Korea, Republic of
19NCT02413580March 20157/4/2015A Study to Assess the Efficacy and Safety of IGIV-C in Patients With Myasthenia Gravis ExacerbationsA 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 ExacerbationsMyasthenia Gravis ExacerbationsBiological: IGIV-CGrifols Therapeutics LLCNULLCompleted18 YearsN/AAll49Phase 3Argentina;Belgium;Canada;Czechia;Estonia;France;Hungary;Latvia;Poland;Romania;Russian Federation;South Africa;Czech Republic
20EUCTR2013-005098-28-CZ16/01/201503/10/2014A 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: 20.0Level: PTClassification code 10028417Term: Myasthenia gravisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3France;Hungary;Estonia;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;South Africa;Latvia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2013-005098-28-HU21/11/201407/10/2014A 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: 19.0Level: PTClassification code 10028417Term: Myasthenia gravisSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 3Estonia;Russian Federation;France;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;South Africa;Netherlands;Latvia
22NCT00306033March 200421/3/2006Intravenous Immune Globulin Treatment Compared to Placebo in Patients With Myasthenia GravisIVIG Treatment Compared to Placebo in Patients With Myasthenia Gravis: A Randomized Clinical TrialMyasthenia GravisDrug: Intravenous ImmuneGlobulinUniversity Health Network, TorontoNULLCompleted18 YearsN/ABoth50Phase 3Canada
23NCT00004682March 199524/2/2000Randomized Study of Intravenous Immunoglobulin in Patients With Mild or Moderate Myasthenia GravisMyasthenia GravisDrug: immune globulinUniversity of TexasNULLTerminated15 YearsN/ABoth100N/ANULL