Immune globulin ( DrugBank: - )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
11重症筋無力症23
13多発性硬化症/視神経脊髄炎7
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9

11. 重症筋無力症


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-003997-18-DE
(EUCTR)
30/05/201627/07/2015A 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: 20.0;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.NULLNot RecruitingFemale: yes
Male: yes
62Phase 2Lithuania;Germany;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;France;United States
2EUCTR2013-005098-28-LV
(EUCTR)
17/12/201522/10/2015A 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]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics LLCNULLNot 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): noFrance;Hungary;Estonia;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;South Africa;Latvia
3EUCTR2013-005099-17-DE
(EUCTR)
18/11/201528/07/2015A 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]
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 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): noFrance;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany
4EUCTR2013-005098-28-EE
(EUCTR)
07/10/201514/09/2015A 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]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics LLCNULLNot 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): noFrance;Hungary;Czech Republic;Estonia;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;South Africa;Latvia
5EUCTR2013-005099-17-BE
(EUCTR)
06/10/201515/01/2016A 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: 19.1;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.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany
6EUCTR2014-003997-18-BE
(EUCTR)
06/10/201518/01/2016A 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: 18.1;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.NULLNot RecruitingFemale: yes
Male: yes
62Phase 2France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany
7EUCTR2013-005099-17-CZ
(EUCTR)
10/09/201517/06/2015A 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]
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 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): noFrance;United States;Hungary;Estonia;Czech Republic;Canada;Belgium;Poland;Lithuania;Germany
8EUCTR2014-003997-18-CZ
(EUCTR)
10/09/201517/06/2015A 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: 20.0;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.NULLNot RecruitingFemale: yes
Male: yes
62Phase 2France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany
9NCT02473952
(ClinicalTrials.gov)
August 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-RO
(EUCTR)
21/07/201510/03/2015A 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: 18.1;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.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3France;Estonia;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Russian Federation;Latvia;Germany
11EUCTR2014-003997-18-HU
(EUCTR)
13/07/201526/05/2015A 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: 18.1;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.NULLNot RecruitingFemale: yes
Male: yes
62Phase 2France;United States;Estonia;Czech Republic;Hungary;Canada;Poland;Belgium;Lithuania;Germany
12EUCTR2013-005099-17-HU
(EUCTR)
13/07/201526/05/2015A 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]
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 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): noFrance;United States;Estonia;Czech Republic;Hungary;Canada;Poland;Belgium;Lithuania;Germany
13EUCTR2014-003997-18-LT
(EUCTR)
07/07/201525/05/2015A 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: 20.0;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.NULLNot RecruitingFemale: yes
Male: yes
62Phase 2France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany
14EUCTR2013-005099-17-LT
(EUCTR)
07/07/201525/05/2015A 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: 20.0;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.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Canada;Czech Republic;Belgium;Hungary;United States;Poland;Lithuania;France;Germany;Estonia
15EUCTR2013-005098-28-PL
(EUCTR)
07/07/201501/06/2015A 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: 20.0;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.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3France;Hungary;Estonia;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Russian Federation;South Africa;Latvia
16EUCTR2014-003997-18-EE
(EUCTR)
22/06/201526/05/2015A 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: 20.0;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.NULLNot RecruitingFemale: yes
Male: yes
62Phase 2France;United States;Hungary;Czech Republic;Estonia;Canada;Poland;Belgium;Lithuania;Germany
17EUCTR2013-005099-17-EE
(EUCTR)
22/06/201526/05/2015A 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]
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 LLCNULLNot 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): noFrance;United States;Hungary;Czech Republic;Estonia;Canada;Poland;Belgium;Lithuania;Germany
18EUCTR2013-005098-28-BE
(EUCTR)
13/03/201512/12/2014A 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: 18.1;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.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
19NCT02413580
(ClinicalTrials.gov)
March 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-CZ
(EUCTR)
16/01/201503/10/2014A 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: 20.0;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.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3France;Hungary;Estonia;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;South Africa;Latvia
21EUCTR2013-005098-28-HU
(EUCTR)
21/11/201407/10/2014A 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.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3Estonia;Russian Federation;France;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;South Africa;Netherlands;Latvia
22NCT00306033
(ClinicalTrials.gov)
March 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
23NCT00004682
(ClinicalTrials.gov)
March 199524/2/2000Randomized Study of Intravenous Immunoglobulin in Patients With Mild or Moderate Myasthenia GravisMyasthenia GravisDrug: immune globulinUniversity of TexasNULLTerminated15 YearsN/ABoth100N/ANULL

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2012-005086-12-PL
(EUCTR)
07/01/201516/09/2014Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulinActive-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial relapsing multiple sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Octagam 50 mg/ml
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif 44 micrograms
INN or Proposed INN: INTERFERON BETA-1a
Trade Name: Betaferon 250 microgram/ml
INN or Proposed INN: INTERFERON BETA-1b
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
234Phase 3Serbia;Hungary;Poland;Ukraine;Austria;Russian Federation;Bulgaria;Germany
2EUCTR2012-005086-12-BG
(EUCTR)
14/11/201319/08/2013Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulinActive-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial relapsing multiple sclerosis
MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Octagam 50 mg/ml
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif 44 micrograms
Product Name: Rebif 44 micrograms
INN or Proposed INN: INTERFERON BETA-1a
Trade Name: Betaferon 250 microgram/ml
Product Name: Betaferon 250 microgram/ml
INN or Proposed INN: INTERFERON BETA-1b
Trade Name: Extavia 250 microgram/ml
Product Name: Extavia 250 microgram/ml
INN or Proposed INN: INTERFERON BETA-1a
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
234Phase 3Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany
3EUCTR2012-005086-12-DE
(EUCTR)
12/11/201301/07/2013Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulinActive-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial relapsing multiple sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Octagam 50 mg/ml
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif 44 micrograms
Product Name: Rebif 44 micrograms
INN or Proposed INN: INTERFERON BETA-1a
Trade Name: Betaferon 250 microgram/ml
Product Name: Betaferon 250 microgram/ml
INN or Proposed INN: INTERFERON BETA-1b
Trade Name: Extavia 250 microgram/ml
Product Name: Extavia 250 microgram/ml
INN or Proposed INN: INTERFERON BETA-1a
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
216Phase 3Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany
4EUCTR2012-005086-12-HU
(EUCTR)
31/07/201318/06/2013Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulinActive-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial relapsing multiple sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Octagam 50 mg/ml
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif 44 micrograms
Product Name: Rebif 44 micrograms
INN or Proposed INN: INTERFERON BETA-1a
Trade Name: Betaferon 250 microgram/ml
Product Name: Betaferon 250 microgram/ml
INN or Proposed INN: INTERFERON BETA-1b
Trade Name: Extavia 250 microgram/ml
Product Name: Extavia 250 microgram/ml
INN or Proposed INN: INTERFERON BETA-1a
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
216Phase 3Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany
5EUCTR2012-005086-12-AT
(EUCTR)
05/07/201308/05/2013Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulinActive-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial relapsing multiple sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Octagam 50 mg/ml
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif 44 micrograms
Product Name: Rebif 44 micrograms
INN or Proposed INN: INTERFERON BETA-1a
Trade Name: Betaferon 250 microgram/ml
Product Name: Betaferon 250 microgram/ml
INN or Proposed INN: INTERFERON BETA-1b
Trade Name: Extavia 250 microgram/ml
Product Name: Extavia 250 microgram/ml
INN or Proposed INN: INTERFERON BETA-1a
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
216Phase 3Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany
6NCT00220779
(ClinicalTrials.gov)
December 200213/9/2005Immune Globulin Intravenous (IGIV) To Treat Relapsing, Remitting Multiple SclerosisRandomized, Double-Blind, Placebo-Controlled Study to Compare the Effects of Different Dose Regimens of IGIV Chromatography (IGIV-C), 10% Treatment on Relapses in Patients With Relapsing Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified;Drug: Albumin (Human) 25%, United States Pharmacopeia (USP)Grifols Therapeutics Inc.NULLCompleted18 Years55 YearsAll128Phase 2United States;Austria;Canada;Czech Republic;Germany;Greece;Hungary;Israel;Poland;Slovakia;Sweden;United Kingdom
7NCT00004744
(ClinicalTrials.gov)
February 199324/2/2000Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple SclerosisMultiple SclerosisDrug: immune globulinNational Institute of Neurological Disorders and Stroke (NINDS)Mayo ClinicCompleted18 Years60 YearsBoth76Phase 3NULL

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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05584631
(ClinicalTrials.gov)
October 18, 202210/10/2022IVIG vs SCIG in CIDPThe Influence of Body Composition on Immunoglobulin Disposition After Intravenous and Subcutaneous AdministrationCIDP;Immunoglobulin Deficiency;Chronic Inflammatory Demyelinating PolyneuropathyDrug: Intravenous immune globulin G;Drug: Subcutaneous immune globulin GRutgers, The State University of New JerseyNULLRecruiting18 Years65 YearsAll20Phase 1United States
2JPRN-jRCT2051210110
07/12/202114/10/2021A Study of TAK-771 in Japanese Participants with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN)A Phase 3 Study to Evaluate the Efficacy, Safety and Tolerability of TAK-771 for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN) in Japanese Subjects Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MMCohort 1: TAK-771 for CIDP Participants
TAK-771 includes Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20). Participants will receive subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 2, 3, or 4 weeks.

Cohort 2: TAK-771 for MMN Participants
TAK-771 includes IGI 10% and rHuPH20. Participants will receive subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 2, 3, or 4 weeks.
Nishizawa AtsushiNULLRecruiting>= 18age oldNot applicableBoth21Phase 3Japan
3NCT03166527
(ClinicalTrials.gov)
June 1, 20178/5/2017Panzyga in CIDP Administered at Different Infusion RatesProspective, Open-Label, Phase IIIb Study Evaluating the Safety, Tolerability and Efficacy of Panzyga® in Patients With Chronic Inflammatory Demyelinating Polyneuropathy Administered at Standard and High Infusion RatesChronic Inflammatory Demyelinating Polyneuropathy (CIDP)Drug: Immune Globulin 10% Intravenous SolutionVera BrilNULLNot yet recruiting18 YearsN/AAll30Phase 3Canada
4NCT02465359
(ClinicalTrials.gov)
September 201412/12/2014Subcutaneous Immunoglobulin for CIDPA Study of Subcutaneous Immunoglobulin as Chronic Treatment for Patients With Chronic Inflammatory Demyelinating PolyneuropathyChronic Inflammatory Demyelinating PolyneuropathyDrug: Immune Globulin Subcutaneous (Human)University of South FloridaCSL BehringCompleted18 Years80 YearsAll20N/AUnited States
5EUCTR2009-017805-13-BG
(EUCTR)
27/01/201113/12/2010Study to evaluate efficacy of human immune globulin in patients with CIDP-chronic neuropathy.PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMISED, MULTICENTRE, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03 Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 14.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: NewGam
Product Code: NewGam
INN or Proposed INN: Immunoglobuline G
Other descriptive name: NewGam
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
172Phase 2/3India;Serbia;Czech Republic;Mexico;Poland;Ukraine;Romania;Bulgaria
6EUCTR2009-013841-27-DK
(EUCTR)
17/12/200927/10/2009A Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multofocl Motor Neuropathy - IGIV, 10% MMN TrialA Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multofocl Motor Neuropathy - IGIV, 10% MMN Trial Multifocal motor neuropathy
MedDRA version: 12.0;Level: LLT;Classification code 10065579;Term: Multifocal motor neuropathy
Trade Name: KIOVIG 100 mg/ml solution for infusion
Product Name: IGIV, 10%
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Baxter Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
40Denmark
7NCT00666263
(ClinicalTrials.gov)
August 200823/4/2008Study of the Effectiveness of Intravenous Immune Globulin (10%) for the Treatment of Multifocal Motor NeuropathyA Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multifocal Motor NeuropathyMultifocal Motor NeuropathyBiological: Immune Globulin Intravenous (human), 10%;Biological: 0.25% human albumin solution (Placebo)Baxalta now part of ShireNULLCompleted18 YearsN/AAll50Phase 3United States;Canada;Denmark;Netherlands;Poland
8NCT00220740
(ClinicalTrials.gov)
April 200413/9/2005Immune Globulin Intravenous (IGIV) For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of IGIV-Chromatography (IGIV-C), 10% Treatment in Subjects With Chronic Inflammatory Demyelinating PolyneuropathyPolyradiculoneuropathy, Chronic Inflammatory DemyelinatingDrug: Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified;Drug: Albumin (Human) 25%, United States Pharmacopeia (USP)Grifols Therapeutics Inc.NULLCompleted18 YearsN/AAll117Phase 3United States;Argentina;Canada;Czech Republic;Germany;Israel;Italy;Mexico;Poland;Serbia;Former Serbia and Montenegro
9NCT00004772
(ClinicalTrials.gov)
September 199224/2/2000Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Chronic Inflammatory Demyelinating PolyneuropathyPolyradiculoneuropathy, Chronic Inflammatory DemyelinatingDrug: Immune globulinNational Center for Research Resources (NCRR)Ohio State UniversityCompleted15 YearsN/ABoth90Phase 3NULL