DDrare: Database of Drug Development for Rare Diseases

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.

Drug = 0.9% sodium chloride; 10% intravenous immunoglobulin (IVIg); 10% liquid formulation of human immunoglobulin; : immunoglobulina umana normale 10% per somministrazione endovenosa; ARGX-113; Acthar; Albumin (Human) 25%, United States Pharmacopeia (USP); Anti-C5 antibody; Anti-Thymocyte Globulin; BIVV020; Biological : I10E (Human normal Immunoglobulin for intravenous administration 100mg/mL); Biological: Kiovig® (Human normal Immunoglobulin for intravenous administration 100mg/mL); CLORFENAMINA MALEATO; Carmustine; Chloride; Clorfenamina; Clorfenamina maleato; Cyclophosphamide; Cytarabine; Device: Vital EMS+; Dexamethasone; Eculizumab; Efgartigimod PH20 SC; Efgartigimod PH20 SC in stage B; Efgartigimod alfa; Etoposide; FAMPRIDINE; FINGOLIMOD HYDROCHLORIDE; FTY720; FTY720I; Fampridine; Fampyra; Fibrinogen; Fibrinogen concentrate; Fingolimod; Freeze-Dried Sulfonated Human Normal Immunoglobulin (GGS); GILENYA 0,5 mg cápsulas duras; Gammanorm; Gilenya; H.P. Acthar® Gel; HIDROCLORURO DE FINGOLIMOD; HUMAN IMMUNOGLOBULIN G; HUMAN NORMAL IMMUNOGLOBULIN; HUMAN NORMAL IMMUNOGLOBULIN (IV); Hematopoietic stem cell transplantation; Hizentra; Hizentra®; Human Immunoglobulin G; Human immunoglobulin G; Human normal 10% immunoglobulin for intravenous administration; Human normal 10% immunoglobulin for intravenous administrationn; Human normal immunoglobulin; Human normal immunoglobulin (SCIg); Human normal immunoglobulin G (IgG > 98% purity); Human normal immunoglobulin for intravenous administration; HyQvia; Hyqvia; I10; I10E; IGIV, 10%; IGVENA*FL 200ML 10G+SET; IMMUNOGLOBULIN G; IMMUNOGLOBULINA UMANA NORMALE per somministrazione endovenosa; IQYMUNE; IVIg; IgPro10; IgPro20; IgPro20 (high dose); IgPro20 (low dose); Immune Globulin 10% Intravenous Solution; Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified; Immune Globulin Intravenous (human), 10%; Immune Globulin Subcutaneous (Human); Immune globulin; Immunoglobulin; Immunoglobulin G; Immunoglobulin perfusion; Immunoglobulina umana normale per somministrazione endovenosa; Immunoglobuline G; Immunoglobulins; Immunoglobulins, normal human, for extravascular adm.; Immunoglobulins, normal human, for intravascular adm.; Intravenous Immunoglobulin; Intravenous immunoglobulin; Intravenous immunoglobulin (IVIg); KIOVIG; KIOVIG 100 mg/ml solution for infusion; Kiovig; Lipoic acid; MABTHERA - 1 FIALA 500 MG 50 ML; MD1003; METILPREDNISOLONE SODIO SUCCINATO; MabThera; Melphalan; Methylprednisolon; Methylprednisolon (Solu-Medrol); Methylprednisolone; Methylprednisolone (Solu-Medrol); Metilprednisolone sodio succinato; NPB-01; NewGam; Other: Fresh Frozen Plasma; Other: Laboratory Biomarker Analysis; PANZYGA; PARACETAMOLO; Paracetamolo; Placebo; Prednisolone; Prednisone; Privigen; Privigen®; Procedure: Autologous Hematopoietic Stem Cell Transplantation; Procedure: Peripheral Blood Stem Cell Transplantation; Procedure: Syngeneic Bone Marrow Transplantation; RHuPH20; RITUXIMAB; ROZANOLIXIZUMAB; RVG 51680; RVG 56083; Rituximab; Rituximab (genetical recombination); Rozanolixizumab; SOLIRIS; SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML; Sodium Chloride 0.9%; Sodium chloride; Sodium chloride 0.9%; Soliris; Standard of Care; Subcutaneous immunoglobulin; Subcuvia; TACHIPIRINA - 1000 MG COMPRESSE 8 COMPRESSE; TRIMETON - 10 MG/1 ML SOLUZIONE INIETTABILE 5 FIALE 1 ML; UCB7665; Vivaglobin; [Clorfenamina maleato]; [Metilprednisolone sodio succinato]; [Paracetamolo]; [Rituximab]

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT02885259 (ClinicalTrials.gov)	September 2016	25/1/2016	HyQvia in Multifocal Motor Neuropathy	Subcutaneous Immunoglobulin With rHuPH20 in Multifocal Motor Neuropathy	Multifocal Motor Neuropathy	Drug: rHuPH20	UMC Utrecht	NULL	Not yet recruiting	18 Years	99 Years	Both	20	N/A	Netherlands
2	EUCTR2015-000828-28-NL (EUCTR)	26/07/2016	30/11/2015	Immunoglobulins 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 Utrecht	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 3	Netherlands
3	NCT02556437 (ClinicalTrials.gov)	June 2016	18/9/2015	Efficacy and Safety of HyQvia (Immunoglobulin 10% With Recombinant Hyaluronidase) in Multifocal Motor Neuropathy (MMN)	Randomized, Single-blind, 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	Drug: HyQvia;Drug: Subcuvia	Johannes Jakobsen	Baxter Healthcare Corporation	Completed	18 Years	90 Years	All	18	Phase 2	Denmark
4	EUCTR2015-003453-18-DK (EUCTR)	25/11/2015	23/09/2015	Study of the effect and safety of a new immunoglobulin preparation (HyQvia) for subcutaneous usage in patients with Multifocal Motor Neuropathy	A 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: 18.1;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: 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	Rigshospitalet	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	Denmark

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT02885259
(ClinicalTrials.gov)

September 2016

25/1/2016

HyQvia in Multifocal Motor Neuropathy

Subcutaneous Immunoglobulin With rHuPH20 in Multifocal Motor Neuropathy

Multifocal Motor Neuropathy

Drug: rHuPH20

UMC Utrecht

NULL

Not yet recruiting

18 Years

99 Years

Both

N/A

Netherlands

EUCTR2015-000828-28-NL
(EUCTR)

26/07/2016

30/11/2015

Immunoglobulins 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 Utrecht

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

Netherlands

NCT02556437
(ClinicalTrials.gov)

June 2016

18/9/2015

Efficacy and Safety of HyQvia (Immunoglobulin 10% With Recombinant Hyaluronidase) in Multifocal Motor Neuropathy (MMN)

Randomized, Single-blind, 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

Drug: HyQvia;Drug: Subcuvia

Johannes Jakobsen

Baxter Healthcare Corporation

Completed

18 Years

90 Years

All

Phase 2

Denmark

EUCTR2015-003453-18-DK
(EUCTR)

25/11/2015

23/09/2015

Study of the effect and safety of a new immunoglobulin preparation (HyQvia) for subcutaneous usage in patients with Multifocal Motor Neuropathy

A 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: 18.1;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: 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

Rigshospitalet

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Denmark