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:145,薬物数:139(DrugBank:23),標的遺伝子数:12,標的パスウェイ数:21

Searched query = "Chronic inflammatory demyelinating polyneuropathy", "Chronic inflammatory demyelinating poly (radiculo) neuropathy", "Multifocal motor neuropathy", "CIDP"
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"
77 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-002438-34-DK19/08/202011/06/2020Fampridine for treatment of functional disability in patients with immune mediated polyneuropathyFampridine for treatment of residual neurological deficits in patients treated with immunoglobulins for chronic inflammatory demyelinating polyneuropathy Chronic inflammatory demyelinating polyneuropathy
MedDRA version: 20.0Level: LLTClassification code 10072650Term: CIDPSystem Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Fampyra
Product Name: Fampyra
INN or Proposed INN: FAMPRIDINE
Department of Neurology, Odense University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Denmark
2NCT04589299June 4, 20209/9/2020Subcutaneous Immunoglobulin in De-novo CIDP (SIDEC)Randomized, Parallel Study of Subcutaneous Versus Intravenous Immunoglobulin in Treatment-naïve Patients With Chronic Inflammatory Demyelinating PolyneuropathyCIDP - Chronic Inflammatory Demyelinating PolyneuropathyBiological: ImmunoglobulinUniversity of AarhusRigshospitalet, Denmark;Aarhus University Hospital;Odense University Hospital;Aalborg University HospitalRecruiting18 YearsN/AAll60Phase 4Denmark
3EUCTR2018-003592-34-DK02/08/201914/03/2019Subcutaneous versus intravenous administration of immunoglobulin in newly diagnosed patients with chronic inflammatory neuropathySubcutaneous immunoglobulin in de-novo CIDP(Randomized, parallel study of subcutaneous versus intravenous immunoglobulin in treatment-naïve patients with chronic inflammatory demyelinating polyneuropathy) - SIDEC Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 21.1Level: PTClassification code 10064135Term: Polyneuropathy chronicSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra
Product Name: Hizentra
INN or Proposed INN: Human Immunoglobulin G
Other descriptive name: HUMAN IMMUNOGLOBULIN G
Trade Name: Privigen
Product Name: Privigen
INN or Proposed INN: Human Immunoglobulin G
Other descriptive name: HUMAN IMMUNOGLOBULIN G
Aarhus University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 4Denmark
4EUCTR2017-002511-34-GB01/04/201908/11/2019Initial treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) - combined immunoglobulin and steroid treatment versus immunoglobulin treatment alone.Intravenous immunoglobulin and intravenous methylprednisolone as optimal induction treatment in CIDP - OPTIC Trial Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 21.1Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: methylprednisolone
Product Name: methylprednisolone
Trade Name: sodium chloride 0.9%
Product Name: sodium chloride 0.9%
Academic Medical Centre, Amsterdam, NLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Phase 3Netherlands;United Kingdom
5NCT03864185March 28, 201919/2/2019The Evaluation of Efficacy and Safety of Rituximab in Refractory CIDP Patients With IgG4 AutoantibodiesThe Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients With Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical TrialChronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Biological: Rituximab (genetical recombination);Other: PlaceboNagoya UniversityJapan Agency for Medical Research and Development;Zenyaku Kogyo Co., Ltd.Active, not recruiting12 YearsN/AAll25Phase 2Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6JPRN-UMIN0000357532019/03/2802/02/2019The Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical TrialThe Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical Trial - RECIPE Trial Chronic Inflammatory Demyelinating PolyneuropathyCIDP patients with positive IgG4 autoantibody (CNTN-1 or NF-155):
Administer 375 mg/m2 of rituximab (genetical recombination) IV infusion once weekly for 4 doses.

CIDP patients with positive IgG4 autoantibody (CNTN-1 or NF-155):
Administer placebo IV infusion once weekly for 4 doses.
CIDP patients with negative IgG4 autoantibody (CNTN-1 and NF-155):
Administer 375 mg/m2 of rituximab (genetical recombination) IV infusion once weekly for 4 doses.
Nagoya University HospitalZenyaku Kogyo Co., Ltd.Complete: follow-up continuing12years-oldNot applicableMale and Female25Phase 2Japan
7JPRN-jRCT204118003728/03/201931/01/2019RECIPE TrialThe Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical Trial - RECIPE Trial Chronic Inflammatory Demyelinating Polyneuropathy
Chronic Inflammatory Demyelinating Polyneuropathy
CIDP patients with positive IgG4 autoantibody (CNTN-1 or NF-155):
Administer 375 mg/m2 of rituximab (genetical recombination) or placebo IV infusion once weekly for 4 doses.
CIDP patients with negative IgG4 autoantibody (CNTN-1 and NF-155):
Administer 375 mg/m2 of rituximab (genetical recombination) IV infusion once weekly for 4 doses.
Iijima MasahiroNULLNot Recruiting>= 12age oldNot applicableBoth25Japan
8EUCTR2017-002511-34-NL26/09/201817/04/2018Intravenous immunoglobulin and intravenous methylprednisolone as optimal induction treatment in CIDP(OPTIC trial)Intravenous immunoglobulin and intravenous methylprednisolone as optimal induction treatment in CIDP(OPTIC trial) - OPTIC trial Chronic inflammatory demyelinating polyneuropathy (CIDP);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Methylprednisolone (Solu-Medrol)
Product Name: Methylprednisolon (Solu-Medrol)
Trade Name: Sodium Chloride 0.9%
Product Name: Sodium Chloride 0.9%
Product Code: RVG 56083
Academisch Medisch CentrumNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Phase 3Netherlands
9EUCTR2017-002024-24-DK08/09/201719/06/2017Systematic reduction in dosage of subcutanoeus immunoglobulin in patients with chronic inflammatory neuropathyRandomized, cohort study of standardized reduction of subcutaneous immunoglobulin treatment in patients with chronic inflammatory demyelinating polyneuropathy Chronic inflammatory demyelinating polyneuroapthy
MedDRA version: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem Organ Class: 100000014567;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gammanorm
Product Name: Gammanorm
INN or Proposed INN: Immunoglobulin
Other descriptive name: HUMAN IMMUNOGLOBULIN G
Trade Name: Hizentra
Product Name: Hizentra
INN or Proposed INN: Immunoglobulin
Other descriptive name: HUMAN IMMUNOGLOBULIN G
Trade Name: Subcuvia
Product Name: Subcuvia
INN or Proposed INN: Immunoglobulin
Other descriptive name: HUMAN IMMUNOGLOBULIN G
Aarhus Unversity HospitalNULLNot RecruitingFemale: yes
Male: yes
60Phase 4Denmark
10EUCTR2015-005443-14-BG07/09/201730/05/2017Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy.Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP)
MedDRA version: 20.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: PANZYGA
Product Name: NewGam
INN or Proposed INN: Immunoglobulin G
Other descriptive name: IMMUNOGLOBULIN G
Octapharma Pharmazeutika Produktionsges.m.b.H.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2015-005443-14-SE29/06/201707/04/2017Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy.Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP)
MedDRA version: 20.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: PANZYGA
Product Name: NewGam
INN or Proposed INN: Immunoglobulin G
Other descriptive name: IMMUNOGLOBULIN G
Octapharma Pharmazeutika Produktionsges.m.b.H.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden
12EUCTR2015-005443-14-CZ01/06/201712/04/2017Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy.Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP)
MedDRA version: 20.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: PANZYGA
Product Name: NewGam
INN or Proposed INN: Immunoglobulin G
Other descriptive name: IMMUNOGLOBULIN G
Octapharma Pharmazeutika Produktionsges.m.b.H.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden
13EUCTR2015-005443-14-DK01/06/201706/04/2017Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy.Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP)
MedDRA version: 19.1Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: PANZYGA
Product Name: NewGam
INN or Proposed INN: Immunoglobulin G
Other descriptive name: IMMUNOGLOBULIN G
Octapharma Pharmazeutika Produktionsges.m.b.H.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Australia;Denmark;Russian Federation;Bulgaria;Germany;Sweden
14EUCTR2015-005443-14-PL16/05/201713/05/2017Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy.Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP)
MedDRA version: 20.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: PANZYGA
Product Name: NewGam
INN or Proposed INN: Immunoglobulin G
Other descriptive name: IMMUNOGLOBULIN G
Octapharma Pharmazeutika Produktionsges.m.b.H.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden
15EUCTR2015-005443-14-HU12/05/201707/04/2017Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy.Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP)
MedDRA version: 19.1Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: PANZYGA
Product Name: NewGam
INN or Proposed INN: Immunoglobulin G
Other descriptive name: IMMUNOGLOBULIN G
Octapharma Pharmazeutika Produktionsges.m.b.H.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3Czech Republic;Hungary;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT02885259September 201625/1/2016HyQvia in Multifocal Motor NeuropathySubcutaneous Immunoglobulin With rHuPH20 in Multifocal Motor NeuropathyMultifocal Motor NeuropathyDrug: rHuPH20UMC UtrechtNULLNot yet recruiting18 Years99 YearsBoth20N/ANetherlands
17EUCTR2013-005558-31-DE10/08/201608/07/2016Exstension of the international study on efficacy and safety of I10E in CIDP patientsInternational, multicentre, efficacy and safety study of I10E in themaintenance treatment of patients with Chronic InflammatoryDemyelinating Polyradiculoneuropathy: Extension of PRISM studyI10E-1302 - PRISM 2 Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 19.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: IQYMUNE
Product Name: Human normal 10% immunoglobulin for intravenous administrationn
Product Code: I10
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
30Phase 3France;Poland;Spain;Turkey;Tunisia;Germany;Italy;United Kingdom
18EUCTR2013-005557-73-DE10/08/201608/07/2016An 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: 19.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem 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
19EUCTR2015-000828-28-NL26/07/201630/11/2015Immunoglobulins given under the skin to treat patients with multifocal motor neuropathy (MMN). To increase the amount of immunoglobulins, an enzyme is added that will temporarily create more space under the skin. This space is filled with immunoglobulins. By this way less infusions should be needed.Titlle: Subcutaneous immunoglobulins with rHuPH20 in multifocal motor neuropathy (MMN) It is an interventional cross-over study where the use of the combination of subcutaneous immunoglobulins together with the enzyme hyaluronidase (rHuPH20) is compared with the current gold standard intravenous immunoglobulins (IVIg). Non-inferiority and tolerability are studied in 20 MMN patients. The reason to add rHuPH20 is to increase volumes per infusion and in this way contribute to reduced frequency of infusions. - Hymne Non-inferiority and safety/tolerance of Hyqvia compared to IVIg in 20 MMN patients with at least one conduction block on EMG and stable on IVIg.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Hyqvia
Product Name: Hyqvia
UMC UtrechtNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 3Netherlands
20EUCTR2015-003453-18-DK25/11/201523/09/2015Study of the effect and safety of a new immunoglobulin preparation (HyQvia) for subcutaneous usage in patients with Multifocal Motor NeuropathyA Randomized, Single-blinded, Cross-over Study investigating the Non-inferiority of Efficacy and Safety of HyQvia in comparison with Conventional Subcutaneous Ig Therapy in Multifocal Motor Neuropathy Multifocal Motor Neuropathy (MMN)
MedDRA version: 18.1Level: PTClassification code 10064135Term: Polyneuropathy chronicSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: HyQvia
Product Name: HyQvia
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Trade Name: Subcuvia
Product Name: Subcuvia
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
RigshospitaletNULLNot RecruitingFemale: yes
Male: yes
20Phase 2Denmark
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2013-005558-31-FR23/07/201526/06/2015Extension of the international study on efficacy and safety of I10E in CIDP patientsInternational, multicentre, efficacy and safety study of I10E in themaintenance treatment of patients with Chronic InflammatoryDemyelinating Polyradiculoneuropathy: Extension of PRISM studyI10E-1302 - PRISM 2 Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 18.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Human normal 10% immunoglobulin for intravenous administrationn
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
30Phase 3France;Morocco;Mexico;Spain;Turkey;Germany;Tunisia;Italy;United Kingdom
22EUCTR2011-003448-28-PL07/07/201506/05/2015Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 19.0Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan
23EUCTR2011-003448-28-EE11/06/201514/05/2015Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 18.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan
24EUCTR2011-003448-28-LT09/06/201521/04/2015Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 18.0Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan
25EUCTR2012-001995-12-IT19/05/201513/03/2013A 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 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: 15.1Level: PTClassification code 10065579Term: Multifocal motor neuropathySystem 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 BIOTECHNOLOGIESNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 3France;Spain;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2013-004157-24-CZ12/03/201524/03/2014Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP)Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 18.0Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
Other descriptive name: Hizentra®
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
80Phase 3United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Netherlands;Germany;Italy;Japan
27NCT02414490March 201513/3/2015IVIg Treatment-Related Fluctuations in CIDP Patients Using Daily Grip Strength MeasurementsIntravenous Immunoglobulin (IVIg) Treatment-Related Fluctuations in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients Using Daily Grip Strength Measurements (GRIPPER)Chronic Inflammatory Demyelinating PolyneuropathyDrug: Intravenous ImmunoglobulinUniversity of MinnesotaBriovaRx Infusion Services;CSL BehringCompleted18 Years85 YearsAll30United States
28EUCTR2013-005558-31-ES18/02/201516/12/2014Exstension of the international study on efficacy and safety of I10E in CIDP patientsInternational, multicentre, efficacy and safety study of I10E in themaintenance treatment of patients with Chronic InflammatoryDemyelinating Polyradiculoneuropathy: Extension of PRISM studyI10E-1302 - PRISM 2 Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 17.1Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Human normal 10% immunoglobulin for intravenous administrationn
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
30Phase 3France;Morocco;Mexico;Spain;Turkey;Germany;Tunisia;Italy;United Kingdom
29NCT02372149February 201512/2/2015IVIg for Demyelination in Diabetes MellitusTreatment With Gamunex 10% Intravenous Immunoglobulin (IVIg) for Patients With Demyelination and Diabetes Mellitus: A Blinded, Placebo-Controlled Crossover Pilot StudyPeripheral Neuropathy;Diabetes Mellitus;Chronic Inflammatory Demyelinating PolyneuropathyDrug: 10% intravenous immunoglobulin (IVIg);Drug: 0.9% sodium chlorideUniversity of TorontoUniversity Health Network, TorontoRecruiting18 YearsN/ABoth25Phase 4Canada
30EUCTR2013-005558-31-IT26/01/201520/05/2015Extension of the international study on efficacy and safety of I10E in CIDP patientsInternational, multicentre, efficacy and safety study of I10E in the maintenance treatment of patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy: Extension of PRISM studyI10E-1302 - PRISM 2 Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 18.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: : immunoglobulina umana normale 10% per somministrazione endovenosa
Product Code: I10E
INN or Proposed INN: immunoglobulina umana normale per somministrazione endovenosa
Other descriptive name: IMMUNOGLOBULINA UMANA NORMALE per somministrazione endovenosa
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
30Phase 3France;Morocco;Mexico;Spain;Turkey;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2013-005557-73-ES03/12/201427/08/2014An 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: 17.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem 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
32EUCTR2013-004157-24-NL02/12/201420/03/2014Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP)Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 18.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
Other descriptive name: Hizentra®
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
80Phase 3United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Germany;Netherlands;Italy;Japan
33EUCTR2013-004157-24-IT01/10/201421/02/2014Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP)Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 16.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
Other descriptive name: Hizentra®
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
70Phase 3United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Israel;Netherlands;Germany;Japan;Italy
34EUCTR2013-005557-73-IT30/09/201427/08/2014An 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: 17.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem 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
35EUCTR2013-005557-73-FR24/09/201426/06/2015An 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: 18.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem 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 BIOTECHNOLOGIESNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42France;Morocco;Mexico;Spain;Turkey;Tunisia;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2013-005363-52-NL10/09/201427/03/2014Intravenous immunoglobulin overtreatment in CIDPIntravenous immunoglobulin overtreatment in chronic inflammatory demyelinating polyneuropathy (CIDP) Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Sodium Chloride 0.9%
Product Name: Sodium Chloride 0.9%
Product Code: RVG 51680
Department of Neurology, Academic Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
37NCT02465359September 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 BehringUnknown status18 Years80 YearsAll20N/AUnited States
38JPRN-JapicCTI-14247204/8/201413/03/2014Phase 3 study of GGS in multifocal motor neuropathy (MMN)Open-label, uncontrolled, before-and-after study of GGS in multifocal motor neuropathy (MMN) (Phase 3 study) Multifocal motor neuropathy (MMN)Intervention name : Freeze-Dried Sulfonated Human Normal Immunoglobulin (GGS)
INN of the intervention : -
Dosage And administration of the intervention : Intravenous drip infusion
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Teijin Pharma LimitedNULLcomplete2074BOTH5Phase 3Japan
39NCT02027701July 30, 20143/1/2014Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Multicenter, Open-label Extension Study to Investigate the Long-term Safety and Efficacy of IgPro20 in Maintenance Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Subjects Completing Study IgPro20_3003Chronic Inflammatory Demyelinating Polyneuropathy (CIDP);Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingBiological: IgPro20CSL BehringNULLCompleted18 YearsN/AAll82Phase 3United States;Australia;Canada;Czechia;France;Germany;Italy;Japan;Netherlands;Spain;United Kingdom;Czech Republic;Finland
40EUCTR2013-004157-24-DE05/06/201425/02/2014Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP)Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 19.0Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
Other descriptive name: Hizentra®
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
80Phase 3United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Netherlands;Germany;Italy;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2013-004157-24-GB30/04/201418/02/2014Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP) Multicenter, open-label extension study to investigate the long-term safety and efficacy of IgPro20 in maintenance treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in subjects completing study IgPro20_3003 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 18.1 Level: PT Classification code 10061811 Term: Demyelinating polyneuropathy System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
CSL Behring GmbHNULLNot Recruiting Female: yes
Male: yes
80 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Netherlands;Germany;Italy;Japan;United Kingdom
42EUCTR2013-004157-24-ES23/04/201427/02/2014Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP)Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 16.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
Other descriptive name: Hizentra®
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
70Phase 3United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Israel;Netherlands;Germany;Italy;Japan
43EUCTR2013-004157-24-FI04/04/201419/03/2014Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP)Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 17.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
Other descriptive name: Hizentra®
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
40Phase 3United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Netherlands;Germany;Italy;Japan
44JPRN-JapicCTI-14247110/3/201413/03/2014Phase 3 study of GGS in chronic inflammatory demyelinating polyneuropathy (CIDP)Open-label, uncontrolled, before-and-after study of GGS in chronic inflammatory demyelinating polyneuropathy (CIDP) (Phase 3 study) Chronic inflammatory demyelinating polyneuropathy(CIDP)Intervention name : Freeze-Dried Sulfonated Human Normal Immunoglobulin (GGS)
INN of the intervention : -
Dosage And administration of the intervention : Intravenous drip infusion
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Teijin Pharma LimitedNULLcomplete2074BOTH30Phase 3Japan
45NCT02111590January 20149/4/2014Immunoglobulin Dosage and Administration Form in CIDP and MMNThe Influence of Immunoglobulin Dosage and Administration on Development of Hemolytic Anemia and Variation on Muscle Strength in Patients With CIDP and MMNChronic Inflammatory Demyelinating Polyneuropathy;Multifocal Motor Neuropathy;Hemolytic AnemiaDrug: ImmunoglobulinsRigshospitalet, DenmarkAarhus University Hospital;Octapharma Pharmazeutika Produktionsges.m.b.H.Completed18 Years80 YearsBoth36N/ADenmark
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT01951924December 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
47EUCTR2012-001995-12-GB01/08/201303/06/2013A 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]
LFB BIOTECHNOLOGIESNULLNot Recruiting Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;Spain;Italy;United Kingdom
48EUCTR2012-001995-12-ES12/07/201312/07/2013A 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: 16.0Level: PTClassification code 10065579Term: Multifocal motor neuropathySystem 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
49EUCTR2012-001995-12-FR03/07/201304/04/2014A 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: 16.1Level: PTClassification code 10065579Term: Multifocal motor neuropathySystem 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
50EUCTR2013-001428-20-DK06/06/201306/06/2013Study of the effect of subcutaneous administration of immunoglobulin in patients with newly diagnosed chronic inflammatory demyelinating polyradiculoneuropathyRandomized, single-blind crossover study of subcutaneous immunoglobulin in newly diagnosed patients with chronic inflammatory demyelinating polyradiculoneuropathy Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 16.0Level: PTClassification code 10064135Term: Polyneuropathy chronicSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra
Product Name: Hizentra
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Trade Name: Privigen
Product Name: Privigen
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Aarhus University HospitalNULLNot RecruitingFemale: yes
Male: yes
Phase 2Denmark
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT01824251April 20131/4/2013Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Chronic Inflammatory Demyelinating Polyneuropathy.NPB-01(Intravenous Immunoglobulin) Maintenance Therapy for Patients With Chronic Inflammatory Demyelinating Polyneuropathy.Chronic Inflammatory Demyelinating PolyneuropathyDrug: NPB-01Nihon Pharmaceutical Co., LtdNULLCompleted20 Years100 YearsBoth49Phase 3Japan
52NCT01827072April 20131/4/2013Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Multifocal Motor Neuropathy.NPB-01(Intravenous Immunoglobulin) Maintenance Therapy for Patients With Multifocal Motor Neuropathy.Multifocal Motor NeuropathyDrug: NPB-01Nihon Pharmaceutical Co., LtdNULLCompleted20 Years100 YearsBoth13Phase 3Japan
53EUCTR2011-003448-28-BE27/09/201202/04/2012Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 18.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan
54EUCTR2011-003448-28-IT23/08/201229/03/2012Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallelgroup phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 14.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
CSL BEHRING GMBHNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Estonia;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Switzerland;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Netherlands;Korea, Republic of
55EUCTR2011-003448-28-GB23/05/201229/03/2012Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 18.1 Level: PT Classification code 10061811 Term: Demyelinating polyneuropathy System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
CSL Behring GmbHNULLNot Recruiting Female: yes
Male: yes
350 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2011-003448-28-AT18/05/201216/03/2012Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 14.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Belgium;Australia;Netherlands;Germany;Korea, Republic of
57EUCTR2011-003448-28-NL11/05/201214/03/2012Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 17.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan
58EUCTR2011-003448-28-CZ09/05/201223/02/2012Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 18.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan
59EUCTR2011-003448-28-ES24/04/201229/02/2012Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP)-the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 14.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CSL Behring GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3Hungary;Germany;Switzerland;Netherlands;France;Italy;Austria;Australia;Finland;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Korea, Republic of;Spain;United States
60EUCTR2011-003448-28-DE20/04/201231/01/2012Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 19.0Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2011-003448-28-FI05/04/201205/03/2012Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 18.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CSL Behring GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 3Japan;United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands
62NCT01545076March 20121/3/2012Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20)Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Phase III Study to Investigate the Efficacy, Safety, and Tolerability of 2 Different Doses of IgPro20 (Subcutaneous Immunoglobulin) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - the PATH StudyChronic Inflammatory Demyelinating Polyneuropathy;PolyradiculoneuropathyBiological: IgPro20 (low dose);Biological: Placebo;Biological: IgPro10;Biological: IgPro20 (high dose)CSL BehringICON Clinical ResearchCompleted18 YearsN/AAll208Phase 3United States;Australia;Belgium;Canada;Czechia;Estonia;Finland;France;Germany;Israel;Italy;Japan;Netherlands;Poland;Spain;United Kingdom;Austria;Czech Republic
63EUCTR2009-017805-13-CZ14/07/201122/04/2010PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, 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-03PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, 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: 14.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders
Product Name: NewGam
Product Code: NewGam
INN or Proposed INN: Immunoglobuline G
Other descriptive name: NewGam
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
172Phase 2;Phase 3Czech Republic;Bulgaria
64EUCTR2009-017805-13-BG27/01/201113/12/2010Study 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: 14.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem 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
65EUCTR2009-017672-24-FI30/11/201010/09/2010This research study will investigate whether the investigational medicine IgPro10 is efficient and safe for patients with chronic inflammatory demyelinating polyneuropathy (CIDP).A single-arm study to demonstrate the efficacy and safety of Privigen in the treatment of subjects with chronic inflammatory demyelinating polyneuropathy (CIDP) Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 14.0Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Privigen®
INN or Proposed INN: Human normal immunoglobulin G (IgG > 98% purity)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
30Finland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT01184846November 201018/8/2010Study of Efficacy and Safety of Privigen in Subjects With Chronic Inflammatory Demyelinating PolyneuropathyA Single-arm Study to Demonstrate the Efficacy and Safety of Privigen in the Treatment of Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Chronic Inflammatory Demyelinating PolyneuropathyBiological: 10% liquid formulation of human immunoglobulinCSL BehringNULLCompleted18 YearsN/AAll31Phase 3Belgium;Finland;France;Germany;Poland
67EUCTR2009-017672-24-BE13/09/201007/07/2010A single-arm study to demonstrate the efficacy and safety of Privigen in the treatment of subjects with chronic inflammatory demyelinating polyneuropathy (CIDP)A single-arm study to demonstrate the efficacy and safety of Privigen in the treatment of subjects with chronic inflammatory demyelinating polyneuropathy (CIDP) Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 13.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders
Trade Name: Privigen®
INN or Proposed INN: Human normal immunoglobulin G (IgG > 98% purity)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
30Phase 3Finland;Belgium
68EUCTR2009-017805-13-RO08/09/201015/07/2010PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, 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-03PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, 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: 12.1Level: LLTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathy
Product Name: NewGam
Product Code: NewGam
INN or Proposed INN: Immunoglobuline G
Other descriptive name: NewGam
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
172Phase 2;Phase 3Czech Republic;Romania;Bulgaria
69EUCTR2009-013841-27-DK17/12/200927/10/2009A 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: 12.0Level: LLTClassification code 10065579Term: 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
70EUCTR2007-000710-37-GB10/04/200815/02/2008A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN)A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN) Patients with multifocal motor neuropathy, who are treated successful with IVIG and had a stable IVIG treatment schedule for at least 12 weeks prior to screening.
MedDRA version: 9.1 Level: LLT Classification code 10065579 Term: Multifocal motor neuropathy
CSL Behring AGNULLNot Recruiting Female: yes
Male: yes
10 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noGermany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2007-000710-37-DE10/12/200710/09/2007A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN)A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN) Patients with multifocal motor neuropathy, who are treated successful with IVIG and had a stable IVIG treatment schedule for at least 12 weeks prior to screening.
MedDRA version: 9.1Level: LLTClassification code 10065579Term: Multifocal motor neuropathy
Trade Name: Vivaglobin
Product Name: Vivaglobin
Other descriptive name: IMMUNOGLOBULIN G
CSL Behring AGNULLNot RecruitingFemale: yes
Male: yes
10United Kingdom;Germany;Italy
72NCT00701662November 200718/6/2008A Study of Purified Human Antibodies Administered Subcutaneously to Patients With Multifocal Motor Neuropathy (MMN)A Multicentre Study of Subcutaneous Immunoglobulin (SCIG) in Patients With Multifocal Motor Neuropathy (MMN)Multifocal Motor Neuropathy (MMN)Biological: VivaglobinCSL BehringNULLCompleted18 YearsN/AAll8Phase 2Italy;Switzerland;United Kingdom;Germany
73EUCTR2007-000710-37-IT04/10/200712/02/2008A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN) - NDA multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN) - ND Maintenance treatment with subcutaneous immunoglobulin (Vivaglobin) in patients with MMN.
MedDRA version: 9.1Level: LLTClassification code 10036105Term: Polyneuropathy
Trade Name: Vivaglobin
INN or Proposed INN: Immunoglobulins, normal human, for extravascular adm.
CSL Behring AGNULLNot RecruitingFemale: yes
Male: yes
10United Kingdom;Germany;Italy
74EUCTR2005-001136-76-IT09/07/200707/09/2007Double blind Randomized Controlled trial of prolonged treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)with high dose intravenous immunoglobulins (IVIg) or intravenous metilprednisolone (IVMP). A phase III study. - IVIg CIDPDouble blind Randomized Controlled trial of prolonged treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)with high dose intravenous immunoglobulins (IVIg) or intravenous metilprednisolone (IVMP). A phase III study. - IVIg CIDP Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 14.1Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: IGVENA*FL 200ML 10G+SET
INN or Proposed INN: Immunoglobulins, normal human, for intravascular adm.
KEDRIONNULLNot RecruitingFemale: yes
Male: yes
Phase 3Italy
75NCT00268788August 200521/12/2005Subcutaneous Immunoglobulin Treatment for Multifocal Motor NeuropathyA Controlled Cross-Over Trial of Subcutaneous Versus Intravenous Immunoglobulin for Multifocal Motor NeuropathyMultifocal Motor NeuropathyDrug: Subcutaneous immunoglobulin;Drug: Intravenous immunoglobulinUniversity of AarhusNULLCompleted18 Years80 YearsBoth10Phase 2Denmark
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT01349270June 20045/5/2011Randomized Open-label Trial to Compare Efficacy and Tolerance of Corticosteroids and IVIgMulticentre Randomized Open-label Trial to Compare Efficacy and Tolerance of Corticosteroids and IVIg in Patients With Chronic Inflammatory Demyelinating Polyneuropathy on a One Year Follow upDemyelinating PolyneuropathyDrug: Immunoglobulin perfusion;Drug: PrednisoneCentre Hospitalier Universitaire de Saint EtienneLaboratoire français de Fractionnement et de BiotechnologiesCompleted18 Years80 YearsBoth40Phase 3France
77NCT00001287December 19903/11/1999Intravenous Immunoglobulin (IVIg) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)The Efficacy of High-Dose Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Demyelinating Diseases;ParaproteinemiasDrug: intravenous immunoglobulin (IVIg)National Institute of Neurological Disorders and Stroke (NINDS)NULLCompletedN/AN/ABoth60Phase 2United States