14. Chronic inflammatory demyelinating polyneuropathy Clinical trials / Disease details


Clinical trials : 167 Drugs : 158 - (DrugBank : 38) / Drug target genes : 13 - Drug target pathways : 23

  
17 trials found
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1JPRN-jRCTs041210046
12/08/202103/08/2021The Evaluation of Efficacy and Safety of Additional Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the 2nd Exploratory Clinical Study in Patients Requested Medical CareThe Evaluation of Efficacy and Safety of Additional Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the 2nd Exploratory Clinical Study in Patients Requested Medical Care - RECIPE-2 Study Refractory Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Chronicity, Demyelination, Peripheral Neuropathy;G618
Administer 375 mg/m2 of rituximab (genetical recombination) IV infusion once weekly for 4 doses.Iijima MasahiroNULLNot Recruiting>= 20age oldNot applicableBoth5Phase 2Japan
2EUCTR2018-003592-34-DK
(EUCTR)
02/08/201914/03/2019Subcutaneous 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: 21.1;Level: PT;Classification code 10064135;Term: Polyneuropathy chronic;System 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
3NCT03864185
(ClinicalTrials.gov)
March 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.Completed12 YearsN/AAll25Phase 2Japan
4JPRN-UMIN000035753
2019/03/2802/02/2019The 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
5JPRN-jRCT2041180037
28/03/201931/01/2019RECIPE 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 applicableBoth25Phase 2Japan
6EUCTR2017-002024-24-DK
(EUCTR)
08/09/201719/06/2017Systematic 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: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System 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
7EUCTR2015-005443-14-BG
(EUCTR)
07/09/201730/05/2017Prospective, 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: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System 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
8EUCTR2015-005443-14-SE
(EUCTR)
29/06/201707/04/2017Prospective, 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: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System 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
9EUCTR2015-005443-14-DK
(EUCTR)
01/06/201706/04/2017Prospective, 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: 19.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System 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
10EUCTR2015-005443-14-CZ
(EUCTR)
01/06/201712/04/2017Prospective, 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: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System 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
11EUCTR2015-005443-14-PL
(EUCTR)
16/05/201713/05/2017Prospective, 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: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System 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-HU
(EUCTR)
12/05/201707/04/2017Prospective, 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: 19.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System 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
13EUCTR2015-005443-14-DE
(EUCTR)
28/04/201705/04/2017 Prospective, 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: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System 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 Recruiting Female: yes
Male: yes
140 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noHungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden
14EUCTR2009-017672-24-FI
(EUCTR)
30/11/201010/09/2010This 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: 14.0;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System 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
15EUCTR2009-017672-24-BE
(EUCTR)
13/09/201007/07/2010A 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: 13.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System 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
16EUCTR2007-000710-37-GB
(EUCTR)
10/04/200815/02/2008A 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
Trade Name: Vivaglobin
Product Name: Vivaglobin
Other descriptive name: IMMUNOGLOBULIN G
CSL Behring AGNULLNot Recruiting Female: yes
Male: yes
10 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noGermany;Italy;United Kingdom
17EUCTR2007-000710-37-DE
(EUCTR)
10/12/200710/09/2007A 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: 9.1;Level: LLT;Classification code 10065579;Term: 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