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 : 167 薬物数 : 158 - (DrugBank : 38) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 23

  
9 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1NCT04929236
(ClinicalTrials.gov)
August 1, 202211/6/2021Study to Evaluate Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) PatientsMulticenter, Prospective, Double-Blinded, Parallel Group, Randomized Phase III Study to Evaluate Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) PatientsPediatric Chronic Inflammatory Demyelinating PolyneuropathyDrug: PanzygaOctapharmaNULLNot yet recruiting2 Years17 YearsAll30Phase 3NULL
2EUCTR2015-005443-14-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
3EUCTR2015-005443-14-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
4EUCTR2015-005443-14-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
5EUCTR2015-005443-14-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
6NCT03166527
(ClinicalTrials.gov)
June 1, 20178/5/2017Panzyga in CIDP Administered at Different Infusion RatesProspective, Open-Label, Phase IIIb Study Evaluating the Safety, Tolerability and Efficacy of Panzyga® in Patients With Chronic Inflammatory Demyelinating Polyneuropathy Administered at Standard and High Infusion RatesChronic Inflammatory Demyelinating Polyneuropathy (CIDP)Drug: Immune Globulin 10% Intravenous SolutionVera BrilNULLNot yet recruiting18 YearsN/AAll30Phase 3Canada
7EUCTR2015-005443-14-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
8EUCTR2015-005443-14-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
9EUCTR2015-005443-14-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