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 Chronic inflammatory demyelinating polyneuropathy Clinical trials / Disease details


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

  
10 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-005557-73-DE
(EUCTR)
10/08/201608/07/2016An international study on efficacy and safety of I10E in CIDP patientsAn international, multicentre, efficacy and safety study of I10E ininitial and maintenance treatment of patients with ChronicInflammatory Demyelinating Polyradiculoneuropathy - PRISM Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 19.0;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]
Trade Name: IQYMUNE
Product Name: human normal immunoglobulin for intravenous administration
Product Code: I10
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
42Phase 3France;Poland;Spain;Turkey;Tunisia;Germany;Italy;United Kingdom
2EUCTR2012-001995-12-IT
(EUCTR)
19/05/201513/03/2013A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy Multifocal motor neuropathy (MMN)
MedDRA version: 15.1;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: KIOVIG
Product Name: KIOVIG
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Product Name: human normal immunoglobulin for intravenous administration
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
20Phase 3France;Spain;United Kingdom;Italy
3EUCTR2013-005557-73-ES
(EUCTR)
03/12/201427/08/2014An international study on efficacy and safety of I10E in CIDP patientsAn international, multicentre, efficacy and safety study of I10E ininitial and maintenance treatment of patients with ChronicInflammatory Demyelinating Polyradiculoneuropathy - PRISM Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 17.0;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: human normal immunoglobulin for intravenous administration
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
42Phase 3France;Morocco;Mexico;Spain;Turkey;Germany;Tunisia;Italy;United Kingdom
4EUCTR2013-005557-73-GB
(EUCTR)
21/10/201415/08/2014An international study on efficacy and safety of I10E in CIDP patients An international, multicentre, efficacy and safety study of I10E in initial and maintenance treatment of patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy - PRISM Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 20.0;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]
Trade Name: IQYMUNE
Product Name: human normal immunoglobulin for intravenous administration
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLNot Recruiting Female: yes
Male: yes
42 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Spain;Turkey;Germany;Tunisia;Italy;United Kingdom
5EUCTR2013-005557-73-IT
(EUCTR)
30/09/201427/08/2014An international study on efficacy and safety of I10E in CIDP patientsAn international, multicentre, efficacy and safety study of I10E ininitial and maintenance treatment of patients with ChronicInflammatory Demyelinating Polyradiculoneuropathy - PRISM Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 17.0;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: human normal immunoglobulin for intravenous administration
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
42Phase 3France;Morocco;Mexico;Spain;Turkey;Germany;Tunisia;United Kingdom;Italy
6EUCTR2013-005557-73-FR
(EUCTR)
24/09/201426/06/2015An international study on efficacy and safety of I10E in CIDP patientsAn international, multicentre, efficacy and safety study of I10E ininitial and maintenance treatment of patients with ChronicInflammatory Demyelinating Polyradiculoneuropathy - PRISM Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 18.0;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: human normal immunoglobulin for intravenous administration
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
42Phase 3France;Morocco;Mexico;Spain;Turkey;Germany;Tunisia;United Kingdom;Italy
7NCT01951924
(ClinicalTrials.gov)
December 201320/9/2013LIME Study (LFB IVIg MMN Efficacy Study)A European, Randomised, Double-blind, Active Comparator Controlled, Cross-over, Efficacy and Safety Study of a New 10% Ready To-use Liquid Human Intravenous Immunoglobulin (I10E) Versus Kiovig® in Patients With Multifocal Motor NeuropathyMotor Neuron DiseaseDrug: Biological : I10E (Human normal Immunoglobulin for intravenous administration 100mg/mL);Drug: Biological: Kiovig® (Human normal Immunoglobulin for intravenous administration 100mg/mL)Laboratoire français de Fractionnement et de BiotechnologiesTFS Trial Form SupportCompleted18 Years80 YearsBoth23Phase 3France;Italy;Spain;United Kingdom
8EUCTR2012-001995-12-GB
(EUCTR)
01/08/201303/06/2013A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor NeuropathyA European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy Multifocal motor neuropathy (MMN)
MedDRA version: 18.0;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: KIOVIG
Product Name: KIOVIG
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Product Name: human normal immunoglobulin for intravenous administration
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLNot Recruiting Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Spain;Italy;United Kingdom
9EUCTR2012-001995-12-ES
(EUCTR)
12/07/201312/07/2013A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor NeuropathyA European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy Multifocal motor neuropathy (MMN)
MedDRA version: 16.0;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: KIOVIG
Product Name: KIOVIG
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Product Name: human normal immunoglobulin for intravenous administration
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
20Phase 3France;Spain;United Kingdom
10EUCTR2012-001995-12-FR
(EUCTR)
03/07/201304/04/2014A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor NeuropathyA European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy Multifocal motor neuropathy (MMN)
MedDRA version: 16.1;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: KIOVIG
Product Name: KIOVIG
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Product Name: human normal immunoglobulin for intravenous administration
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
20Phase 3France;Spain;United Kingdom