Ivig    (DrugBank: IVIg)

8 diseases
告示番号疾患名(ページ内リンク)臨床試験数
11重症筋無力症4
13多発性硬化症/視神経脊髄炎6
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10
17多系統萎縮症1
35天疱瘡2
50皮膚筋炎/多発性筋炎7
51全身性強皮症2
65原発性免疫不全症候群14

11. 重症筋無力症 [臨床試験数:226,薬物数:172(DrugBank:45),標的遺伝子数:43,標的パスウェイ数:118
Searched query = "Myasthenia", "MG"
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.
4 / 226 trials found
No.TrialIDDate_
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PhaseCountries
1NCT04101578
(ClinicalTrials.gov)
February 8, 201716/9/2019Clinical Prognosis and Progression of Myasthenia Gravis PatientsProspective Observational Trial to Evaluate Clinical Prognosis and the Risk Factors for Progression for Myasthenia Gravis PatientsMyasthenia GravisDrug: Symptomatic Treatment, Steroids, Immunosuppressive Agents, Plasma Exchange(PE), Intravenous Immunoglobulin(IVIg)Da, Yuwei, M.D.NULLRecruiting15 YearsN/AAll2000China
2JPRN-UMIN000015019
2014/09/0202/09/2014Initial therapy for myasthenia gravis of combined therapy for tacrolimus and IVIG Myasthenia gravisTacrolimus and IVIGKansai medical universityNULLRecruitingNot applicableNot applicableMale and Female20Not applicableJapan
3NCT01179893
(ClinicalTrials.gov)
March 20079/8/2010Intravenous Immunoglobulin and Plasma Exchange in Myasthenia GravisA Randomized Trial of Plasma Exchange vs. IVIG in the Treatment of Myasthenia GravisMyasthenia GravidBiological: IVIG;Procedure: PLEXUniversity Health Network, TorontoGrifols Therapeutics Inc.Completed18 YearsN/ABoth87Phase 4Canada
4NCT00306033
(ClinicalTrials.gov)
March 200421/3/2006Intravenous Immune Globulin Treatment Compared to Placebo in Patients With Myasthenia GravisIVIG Treatment Compared to Placebo in Patients With Myasthenia Gravis: A Randomized Clinical TrialMyasthenia GravisDrug: Intravenous ImmuneGlobulinUniversity Health Network, TorontoNULLCompleted18 YearsN/ABoth50Phase 3Canada

13. 多発性硬化症/視神経脊髄炎 [臨床試験数:3,050,薬物数:2,147(DrugBank:348),標的遺伝子数:244,標的パスウェイ数:228
Searched query = "Multiple sclerosis", "Neuromyelitis optica", "MS", "NMOSD", "Devic disease", "Balo concentric sclerosis", "Baló concentric sclerosis"
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.
6 / 3,050 trials found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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agemax
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gender
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size
PhaseCountries
1NCT03829566
(ClinicalTrials.gov)
November 20191/2/2019Autologous Transplant To End NMO Spectrum DisorderAutologous Hematopoietic Stem Cell Transplant for Neuromyelitis Optica Spectrum Disorder (NMOSD)Neuromyelitis Optica;Devic's Disease;NMO Spectrum DisorderDrug: Rituximab;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: G-CSF;Biological: IVIg;Biological: Autologous Stem CellsNorthwestern UniversityNULLWithdrawn18 Years65 YearsAll0Phase 2/Phase 3United States
2NCT03342638
(ClinicalTrials.gov)
November 8, 20179/11/2017Maximizing Outcome of Multiple Sclerosis TransplantationMaximizing Outcome of Multiple Sclerosis Transplantation: MOST TrialMultiple Sclerosis, Relapsing-RemittingDrug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: G-CSF;Biological: IVIg;Biological: Autologous Stem CellsNorthwestern UniversityNULLTerminated18 Years58 YearsAll66Phase 3United States
3NCT02398994
(ClinicalTrials.gov)
March 201523/3/2015A Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin Versus Standard Therapy for Transverse MyelitisA Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin (IVIg) Versus Standard Therapy for the Treatment of Transverse Myelitis in Adults and ChildrenMyelitis, Transverse;Neuromyelitis OpticaDrug: Intravenous Methylprednisolone;Drug: Intravenous ImmunoglobulinGuy's and St Thomas' NHS Foundation TrustKing's College London;Barts and the London School of Medicine and Dentistry;Cardiff University;University College, London;King's College Hospital NHS Trust;Great Ormond Street Hospital for Children NHS Foundation Trust;Barts & The London NHS Trust;Alder Hey Children's NHS Foundation Trust;Walton Centre NHS Foundation Trust;Oxford University Hospitals NHS Trust;Birmingham Children's Hospital NHS Foundation Trust;University Hospital Birmingham NHS Foundation Trust;Cardiff and Vale University Health Board;North Bristol NHS Trust;University Hospitals Bristol NHS Foundation Trust;Central Manchester University Hospitals NHS Foundation Trust;Salford Royal NHS Foundation Trust;University Hospital Southampton NHS Foundation Trust.;Newcastle-upon-Tyne Hospitals NHS Trust;Nottingham University Hospitals NHS Trust;NHS LothianTerminated1 YearN/ABoth2Phase 3United Kingdom
4EUCTR2014-002335-34-GB
(EUCTR)
30/10/201423/10/2014Intravenous immunoglobulin vs standard therapy for treatment of transverse myelitisA multicentre randomiSed controlled TRial of IntraVEnous immunoglobulin (IVIg) versus standard therapy for the treatment of transverse myelitis in adults and children - STRiVE Transverse myelitis (TM) (acute, first onset cases), including first presentation of neuromyelitis optica (NMO)
MedDRA version: 17.1;Level: PT;Classification code 10028527;Term: Myelitis transverse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.1;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: Intratect
Product Name: Intratect
Guy's and St Thomas NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
0Phase 3United Kingdom
5EUCTR2008-004579-22-DE
(EUCTR)
31/03/200907/11/2008A prospective, multicentre, open label, exploratory study to investigate the ability of the Heidelberg Assay Panel and the B-cell/Antibody Response Panel to predict the clinical efefct of Octagam 5% in subjects with relapsing/remitting Multiple SclerosisA prospective, multicentre, open label, exploratory study to investigate the ability of the Heidelberg Assay Panel and the B-cell/Antibody Response Panel to predict the clinical efefct of Octagam 5% in subjects with relapsing/remitting Multiple Sclerosis Subjects with RR Multiple Sclerosis in whom intravenous immunoglobulin (IVIG) treatment is clinically indicated because first-line treatments are contraindicated or not tolerated.
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: octagam
Product Name: Octagam 5%
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
30Austria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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agemin
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agemax
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gender
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PhaseCountries
6EUCTR2008-004579-22-AT
(EUCTR)
14/10/200815/09/2008A prospective, multicentre, open label, exploratory study to investigate the ability of the Heidelberg Assay Panel and the B-Cell /Antibody response panel to predict the clinical effect of Octagam 5% in subjects with relapsing/remitting (RR) multiple sclerosis (MS)A prospective, multicentre, open label, exploratory study to investigate the ability of the Heidelberg Assay Panel and the B-Cell /Antibody response panel to predict the clinical effect of Octagam 5% in subjects with relapsing/remitting (RR) multiple sclerosis (MS) Subjects with RR Multiple Sclerosis in whom intravenous immunoglobulin (IVIG) treatment is clinically indicated because first-line treatments are contraindicated or not tolerated.Trade Name: Octagam 5%
Product Name: Octagam 5%
INN or Proposed INN: Immunoglobulin
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
30Austria

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.
10 / 145 trials found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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PhaseCountries
1EUCTR2015-000828-28-NL
(EUCTR)
26/07/201630/11/2015Immunoglobulins 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
2NCT02414490
(ClinicalTrials.gov)
March 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
3NCT02372149
(ClinicalTrials.gov)
February 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
4EUCTR2013-004988-32-NL
(EUCTR)
22/01/201420/01/2014Pharmacokinetics of IVIg treatment in patients with CIDPRotterdam Observational Study in CIDP of Pharmacokinetics of Intravenous ?-globulin - ROCKY-1 Chronic Inflammatory Demyelinating Polyneuropathy;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Kiovig
Product Name: Kiovig
Erasmus MCNULLNot RecruitingFemale: yes
Male: yes
Phase 4Netherlands
5NCT01951924
(ClinicalTrials.gov)
December 201320/9/2013LIME Study (LFB IVIg MMN Efficacy Study)A European, Randomised, Double-blind, Active Comparator Controlled, Cross-over, Efficacy and Safety Study of a New 10% Ready To-use Liquid Human Intravenous Immunoglobulin (I10E) Versus Kiovig® in Patients With Multifocal Motor NeuropathyMotor Neuron DiseaseDrug: Biological : I10E (Human normal Immunoglobulin for intravenous administration 100mg/mL);Drug: Biological: Kiovig® (Human normal Immunoglobulin for intravenous administration 100mg/mL)Laboratoire français de Fractionnement et de BiotechnologiesTFS Trial Form SupportCompleted18 Years80 YearsBoth23Phase 3France;Italy;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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agemax
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gender
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size
PhaseCountries
6EUCTR2007-000710-37-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
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
7EUCTR2007-000710-37-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
8EUCTR2005-001136-76-IT
(EUCTR)
09/07/200707/09/2007Double 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: 14.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: IGVENA*FL 200ML 10G+SET
INN or Proposed INN: Immunoglobulins, normal human, for intravascular adm.
KEDRIONNULLNot RecruitingFemale: yes
Male: yes
Phase 3Italy
9NCT01349270
(ClinicalTrials.gov)
June 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
10NCT00001287
(ClinicalTrials.gov)
December 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

17. 多系統萎縮症 [臨床試験数:107,薬物数:153(DrugBank:48),標的遺伝子数:59,標的パスウェイ数:104
Searched query = "Multiple system atrophy", "MSA-C", "MSA-P", "Olivopontocerebellar atrophy", "OPCA", "Striatonigral degeneration", "Shy-Drager syndrome"
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.
1 / 107 trial found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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1NCT00750867
(ClinicalTrials.gov)
June 20089/9/2008Treatment of Multiple System Atrophy Using Intravenous ImmunoglobulinsTreatment of Multiple System Atrophy Using Intravenous ImmunoglobulinsMultiple System AtrophyDrug: intravenous immunoglobulin (IVIg)University of Massachusetts, WorcesterNULLCompleted18 YearsN/AAll9Phase 2United States

35. 天疱瘡 [臨床試験数:87,薬物数:114(DrugBank:37),標的遺伝子数:17,標的パスウェイ数:158
Searched query = "Pemphigus"
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.
2 / 87 trials found
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1NCT04400994
(ClinicalTrials.gov)
June 20, 202027/4/2020IVIG With Rituximab vs Rituximab as First Line Treatment of PemphigusThe Use of IVIG in Combination With Rituximab VS Rituximab as the First Line Treatment of PemphigusPemphigusDrug: Rituximab;Other: IVIgThe University of Hong KongNULLRecruiting18 Years70 YearsAll20Phase 2Hong Kong
2NCT00483119
(ClinicalTrials.gov)
April 20075/6/2007Randomized Trial of IVIg With or Without Cyclophosphamide in PemphigusPhase 2 Randomized Trial of IVIg With or Without Cyclophosphamide in PemphigusPemphigus VulgarisDrug: intravenous immunoglobulin;Drug: cyclophosphamideNew York University School of MedicineNULLTerminated18 Years85 YearsAll9Phase 2United States

50. 皮膚筋炎/多発性筋炎 [臨床試験数:157,薬物数:207(DrugBank:76),標的遺伝子数:47,標的パスウェイ数:142
Searched query = "Dermatomyositis", "Polymyositis"
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.
7 / 157 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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PhaseCountries
1JPRN-UMIN000032193
2018/04/1113/04/2018Efficacy and safety of combination therapy of corticosteroid and tacrolimus for patients with anti-melanoma differentiation antigen 5 antibody-positive dermatomyositis-associated interstitial lung disease: a prospective multicenter clinical trialEfficacy and safety of combination therapy of corticosteroid and tacrolimus for patients with anti-melanoma differentiation antigen 5 antibody-positive dermatomyositis-associated interstitial lung disease: a prospective multicenter clinical trial - Combination therapy of corticosteroid and tacrolimus for anti-MDA5 antibody-positive DM-ILD anti-melanoma differentiation antigen 5 antibody-positive dermatomyositis (DM)/clinically amyopathic dermatomyositis (CADM)-associated interstitial lung diseasePatients without poor prognostic factors:
combination therapy of corticosteroid (prednisolone) and tacrolimus for 12 months

Initial dose of oral prednisolone is 0.7 - 1mg/kg/day (Maximum dose of prednisolone is 60mg/body/day). Intravenous methylprednisolone pulse therapy (0.5 - 1g/day for 3 days) is permitted according to the initial disease activity.
After 4 weeks of initial treatment, prednisolone is tapered by approximately 10 to 20% every 2 to 4 weeks and continued at dose of 0.125 mg/kg/day or more in the study period (12 months).

Tacrolimus is administered orally at initial dose of 0.075 mg/kg/day (twice daily) and adjusted over time to maintain a whole-blood trough level of 5 - 10 ng/ml.

For patients with poor prognostic factors, attending physician can chose any treatments (e.g. corticosteroid, immunosuppressant, IVIG). The patients were followed up for 12 months.
Second Division, Department of Internal Medicine, Hamamatsu University School of MedicineNULLRecruiting20years-old80years-oldMale and Female40Not selectedJapan
2EUCTR2005-002463-88-HU
(EUCTR)
11/03/201001/10/2009Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled studyEfficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study Idiopathic DM and PM with insufficiently improved muscle strenght under conventional therapy(Glucocorticosteroids associated with immunosuppresors)Trade Name: Ig Vena
Product Name: Ig VENA (10g/200mL)
Product Code: L0133
OrfagenNULLNot RecruitingFemale: yes
Male: yes
44Hungary;Czech Republic;Germany;Italy;Austria
3EUCTR2005-002463-88-CZ
(EUCTR)
16/12/200905/10/2009Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study.Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study. Idiopathic DM and PM with insufficiently improved muscle strenght under conventional therapy (Glucocorticosteroids associated with immunosuppressors)Trade Name: Ig Vena
Product Name: Ig VENA (10g/200mL)
Product Code: L0133
Other descriptive name: Human normal immunoglogulin (IVIg)
OrfagenNULLNot RecruitingFemale: yes
Male: yes
44Hungary;Germany;Czech Republic;Italy;Austria
4EUCTR2005-002463-88-IT
(EUCTR)
17/08/200621/04/2006fficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM)Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study. Idiopathic dermatomyositis and polymyositis with insufficiently improved muscle strength under conventional therapy (glucocorticosteroids associated with immunosuppressors).
MedDRA version: 14.1;Level: HLT;Classification code 10003821;Term: Muscular autoimmune disorders;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: IGVENA*FL 200ML 10G+SETORFAGENNULLNot RecruitingFemale: yes
Male: yes
44Czech Republic;Hungary;Austria;Germany;Italy
5EUCTR2005-002463-88-DE
(EUCTR)
18/07/200628/12/2005Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled studyEfficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study Idiopathic DM and PM with insufficiently improved muscle strength under conventional therapy (Glucocorticosteroids associated with immunosuppressors).Trade Name: Ig VENA
Product Name: Ig VENA (10g/200mL)
Product Code: L0133
Other descriptive name: Human normal immunoglobulin (IVIg)
OrfagenNULLNot RecruitingFemale: yes
Male: yes
44Hungary;Czech Republic;Germany;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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gender
Target_
size
PhaseCountries
6EUCTR2005-002463-88-AT
(EUCTR)
02/02/200617/01/2006Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled studyEfficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study Idiopathic DM and PM with insufficiently improved muscle strength under conventional therapy (Glucocorticosteroids associated with immunosuppressors).Trade Name: Ig VENA
Product Name: Ig VENA (10g/200mL)
Product Code: L0133
Other descriptive name: Human normal immunoglobulin (IVIg)
OrfagenNULLNot RecruitingFemale: yes
Male: yes
44Hungary;Czech Republic;Germany;Italy;Austria
7NCT00001261
(ClinicalTrials.gov)
May 19903/11/1999Intravenousimmunoglobulin (IVIg) for the Treatment of Inflammatory MyopathiesThe Efficacy of High-Dose Intravenous Immunoglobulin in Patients With Inflammatory Myopathies: A Three Month Randomized Trial With Option for Cross-OverDermatomyositis;Inclusion Body Myositis;PolymyositisDrug: Gamma GlobulinNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompletedN/AN/ABoth120Phase 2United States

51. 全身性強皮症 [臨床試験数:466,薬物数:536(DrugBank:142),標的遺伝子数:110,標的パスウェイ数:210
Searched query = "Scleroderma", "Systemic sclerosis", "SSc", "dcSSc", "lcSSc"
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.
2 / 466 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
1NCT03593902
(ClinicalTrials.gov)
May 17, 201828/6/2018Cardiac Safe Transplants for Systemic SclerosisAutologous Hematopoietic Stem Cell Transplant for Patients With Systemic Sclerosis and Cardiac DysfunctionSystemic Sclerosis;SclerodermaDrug: Rituximab;Drug: Fludarabine;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: G-CSF;Biological: IVIg;Biological: Autologous Stem CellsNorthwestern UniversityNULLTerminated18 Years65 YearsAll9Phase 2/Phase 3United States
2NCT01785056
(ClinicalTrials.gov)
April 201328/1/2013IVIG Treatment in Systemic SclerosisA Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Efficacy of Intravenous Immunoglobulin Treatment in Patients With Systemic SclerosisSystemic Sclerosis;Diffuse SclerodermaBiological: PrivigenGeorgetown UniversityCSL BehringUnknown status18 YearsN/AAll14N/AUnited States

65. 原発性免疫不全症候群 [臨床試験数:413,薬物数:581(DrugBank:97),標的遺伝子数:68,標的パスウェイ数:202
Searched query = "Primary immunodeficiency", "X-SCID", "Reticular dysgenesis", "Adenosine deaminase deficiency", "Omenn syndrome", "Purine nucleoside phosphorylase deficiency", "CD8 deficiency", "ZAP-70 deficiency", "MHC class I deficiency", "MHC class II deficiency", "Combined immunodeficiency", "Wiskott-Aldrich syndrome", "Telangiectasia ataxia", "Nijmegen breakage syndrome", "Bloom syndrome", "Immunodeficiency, centromere region instability, facial anomalies syndrome", "ICF syndrome", "PMS2 deficiency", "Radiosensitivity, immunodeficiency, dysmorphic features, and learning difficulties syndrome", "RIDDLE syndrome", "Schimke syndrome", "Netherton syndrome", "Thymic hypoplasia", "DiGeorge syndrome", "22q11.2 deletion syndrome", "Hyper-IgE syndrome", "Hepatic venoocclusive immunodeficiency", "Immunodeficiency with central hepatic vein atresia", "Dyskeratosis congenita", "X-linked agammaglobulinaemia", "Common variable immunodeficiency", "Hyper-IgM syndrome", "Isolated IgG subclass deficiency", "Selective IgA deficiency", "Specific antibody production deficiency", "Infant transient hypogammaglobulinemia", "Chédiak-Higashi syndrome", "Chediak-Higashi syndrome", "X-linked lymphoproliferative syndrome", "SAP deficiency", "SH2D1A/SLAM-associated protein deficiency", "XIAP deficiency", "X-linked inhibitor of apoptosis deficiency", "Autoimmune lymphoproliferative syndrome", "ALPS", "Familial hemophagocytic syndrome", "Perforin deficiency", "Munc13-4 deficiency", "Syntaxin 11 deficiency", "Munc18-2 deficiency", "Autoimmune polyendocrinopathy-candidiasis-ectodermal dystrophy", "APECED", "Immune dysregulation, polyendocrinopathy, enteropathy, X-linked syndrome", "IPEX syndrome", "CD25 deficiency", "ITCH deficiency", "Primary phagocytic dysfunction", "Severe congenital neutropenia", "Cyclic neutropenia", "Hermanskyi-Pudlak syndrome type 2", "Hermanskyi-Pudlak syndrome 2", "Griscelli syndrome type 2", "Griscelli syndrome 2", "p14 deficiency", "Warts, hypogammaglobulinemia, infections, myelokathexis syndrome", "WHIM syndrome", "Glycogen storage disease type Ib", "Leukocyte adhesion deficiency", "Shwachman-Diamond syndrome", "Chronic granulomatous disease", "Myeloperoxidase deficiency", "Mendelian susceptibility to mycobacterial disease", "MSMD", "Anhidrotic ectodermal dysplasia with immunodeficiency", "EDA-ID", "Interleukin-1 receptor-associated kinase-4 deficiency", "IRAK4 deficiency", "IMyD88 deficiency", "Chronic mucocutaneous candidiasis", "Epidermodysplasia verruciformis", "Herpes simplex encephalitis", "Caspase recruitment domain family member 9 deficiency", "CARD9 deficiency", "Trypanosomiasis", "Congenital complement deficiency", "C1q deficiency", "CC1r deficiency", "CC1s deficiency", "CC2 deficiency", "CC3 deficiency", "CC4 deficiency", "CC5 deficiency", "CC6 deficiency", "CC7 deficiency", "CC8 deficiency", "CC9 deficiency", "Factor D deficiency", "Properdin deficiency", "Factor I deficiency", "Factor H deficiency", "MASP1 deficiency", "3MC syndrome", "Mannose-binding protein-associated serine protease 2 deficiency", "MASP2 deficiency", "FCN3", "Hereditary angioedema type 1", "Hereditary angioedema type I", "C1 inhibitor deficiency type 1", "C1 inhibitor deficiency type I", "Hereditary angioedema type 2", "Hereditary angioedema type II", "C1 inhibitor deficiency type 2", "C1 inhibitor deficiency type II", "Hereditary angioedema type 3", "Hereditary angioedema type III", "C1 inhibitor deficiency type 3", "C1 inhibitor deficiency type III"
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.
14 / 413 trials found
No.TrialIDDate_
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1NCT04561115
(ClinicalTrials.gov)
October 6, 202010/9/2020A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral ImmunodeficiencyA Phase 3, Multicenter, Open-label, Single-sequence, Cross-over, Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of IVIG-PEG Compared to Gamunex-C in Subjects With Primary Humoral ImmunodeficiencyPrimary ImmunodeficiencyBiological: Gamunex-C;Biological: IVIG-PEGGrifols Therapeutics LLCNULLRecruiting18 Years75 YearsAll25Phase 3United States
2EUCTR2020-001496-32-SK
(EUCTR)
01/10/202002/07/2020Study, in which all know the treatment assigned to the patient, conducted in more sites, to evaluate the efficaty, safety, and metabolism of Kedrion in venous Human Normal Immunoglobulin (IVIg) 10% in child with Primary Immunodeficiency Disease (PID)A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety, and Pharmacokinetics of Kedrion Intravenous Human Normal Immunoglobulin (IVIg) 10% in Pediatric Patients Affected by Primary Immunodeficiency Disease (PID) - PID-PED study Pediatric Patients Affected by Primary Immunodeficiency Disease.
MedDRA version: 20.0;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: KIg10
Product Code: KIg10
INN or Proposed INN: Human Immunoglobulin
KEDRION S.P.ANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 3Portugal;Hungary;Slovakia;Russian Federation;Italy
3EUCTR2020-001496-32-HU
(EUCTR)
09/09/202002/07/2020Study, in which all know the treatment assigned to the patient, conducted in more sites, to evaluate the efficaty, safety, and metabolism of Kedrion in venous Human Normal Immunoglobulin (IVIg) 10% in child with Primary Immunodeficiency Disease (PID)A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety, and Pharmacokinetics of Kedrion Intravenous Human Normal Immunoglobulin (IVIg) 10% in Pediatric Patients Affected by Primary Immunodeficiency Disease (PID) - PID-PED study Pediatric Patients Affected by Primary Immunodeficiency Disease.
MedDRA version: 20.0;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: KIg10
Product Code: KIg10
INN or Proposed INN: Human Immunoglobulin
KEDRION S.P.ANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 3Portugal;Hungary;Slovakia;Russian Federation;Italy
4NCT03961009
(ClinicalTrials.gov)
April 30, 201921/5/2019Clinical Assessment of phaRmacokinetics, Efficacy, and Safety of 10% IVIg in PID PatientsA Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety and Pharmacokinetics of Kedrion Intravenous Immunoglobulin (IVIg) 10% in Primary Immunodeficiency Disease (PID) PatientsPrimary Immunodeficiency DiseaseBiological: Kedrion IVIG 10%Kedrion S.p.A.NULLActive, not recruiting2 Years70 YearsAll47Phase 3United States;Canada
5NCT03576469
(ClinicalTrials.gov)
June 13, 201815/6/2018A Study to Evaluate the Benefit of RUCONEST® in Subjects Who Experience ADRs Related to IVIG InfusionsA Single-site, Open-Label, Pilot Study to Evaluate the Benefit of RUCONEST® in Subjects Who Experience ADRs Related to IVIG InfusionsCVI - Common Variable ImmunodeficiencyBiological: C1-esterase inhibitor [recombinant] (C1-INH-R)IMMUNOe Research CentersNULLRecruiting18 YearsN/AAll20Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT01985373
(ClinicalTrials.gov)
December 201331/10/2013Pharmacokinetics and Safety of IVIG Nanogam 100 mg/mlPharmacokinetics and Safety of the Intravenous Human Immunoglobulin Product Nanogam 100 mg/mlPrimary ImmunodeficiencyDrug: Intravenous immunoglobulin infusionSanquinNULLCompleted18 YearsN/ABoth23Phase 3Netherlands
7EUCTR2012-005727-32-NL
(EUCTR)
25/07/201323/05/2013The pharmacokinetics (the behaviour in the body) and safety of the intravenous immunoglobulin product Nanogam 100 mg/mlPharmacokinetics and safety of the intravenous human immunoglobulin product Nanogam 100 mg/ml - PK and safety of Nanogam 100 mg/ml Primary a- or hypogammaglobulinemia
MedDRA version: 14.1;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency;System Organ Class: 100000004870
MedDRA version: 14.1;Classification code 10010509;Term: Congenital hypogammaglobulinemia;System Organ Class: 100000004850
MedDRA version: 14.1;Classification code 10071133;Term: Congenital agammaglobulinemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nanogam 100 mg/ml
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: IVIG
Trade Name: Nanogam® 50 mg/ml
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: IVIG
Sanquin Blood Supply FoundationNULLNot RecruitingFemale: yes
Male: yes
Netherlands
8NCT01581593
(ClinicalTrials.gov)
November 201216/4/2012Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID)Multicenter, Open-label, Historically Controlled, Phase III Study to Assess the Efficacy, Tolerability, Safety and Pharmacokinetics of Kedrion IVIG 10% in Adult and Pediatric Subjects With Primary Immunodeficiency (PID).Primary Immunodeficiency;Agammaglobulinemia;Hypogammaglobulinemia;Antibody DeficiencyBiological: Kedrion IVIG 10%Kedrion S.p.A.NULLActive, not recruiting2 Years70 YearsBoth50Phase 3United States;Canada
9NCT01406470
(ClinicalTrials.gov)
September 201126/7/2011Phase 3 Study of Immune Globulin Intravenous (Human)IVIG-SN™ in Subjects With Primary ImmunodeficiencyAn Open-Label, Single-Arm, Historically Controlled, Prospective, Multicenter Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Immune Globulin Intravenous (Human) IVIG-SN™ in Subjects With Primary ImmunodeficiencyImmunologic Deficiency SyndromeDrug: Immune Globulin Intravenous (Human) 5% Liquid, IVIG-SN™Green Cross CorporationAtlantic Research GroupCompleted2 Years70 YearsBoth45Phase 3United States;Canada
10EUCTR2010-019249-25-HU
(EUCTR)
22/09/201006/08/2010Eine offene, prospektive Studie zur Untersuchung der Pharmakokinetikund Sicherheit (Teil A) des Immunglobulins vom Menschen zurintravenösen Infusion (IVIG) BT090 sowie der Verträglichkeit undSicherheit von steigenden Infusionsgeschwindigkeiten (Teil B) beiPatienten mit primären Immundefekten (PID)An open, prospective trial investigating pharmacokinetics and safety (Part A) of the human normal immunoglobulin for intravenous infusion (IVIG) BT090 and tolerability and safety of escalating infusion rates (Part B) in patients with primary immunodeficiency disease (PID) Primary immunodeficiency disease (PID)
MedDRA version: 13.1;Level: LLT;Classification code 10010509;Term: Congenital hypogammaglobulinemia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Intratect
Product Code: BT090
Other descriptive name: Human normal immunoglobulin for intravenous use (IVIG)
Biotest AGNULLNot RecruitingFemale: yes
Male: yes
30Hungary;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2010-019249-25-DE
(EUCTR)
12/08/201014/05/2010An open, prospective trial investigating pharmacokinetics and safety (Part A) of the human normal immunoglobulin for intravenous infusion (IVIG) BT090 and tolerability and safety of escalating infusion rates (Part B) in patients with primary immunodeficiency disease (PID)An open, prospective trial investigating pharmacokinetics and safety (Part A) of the human normal immunoglobulin for intravenous infusion (IVIG) BT090 and tolerability and safety of escalating infusion rates (Part B) in patients with primary immunodeficiency disease (PID) Primary immunodeficiency disease (PID)
MedDRA version: 14.1;Level: LLT;Classification code 10010509;Term: Congenital hypogammaglobulinemia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Intratect
Product Code: BT090
Other descriptive name: Human normal immunoglobulin for intravenous use (IVIG)
Biotest AGNULLNot RecruitingFemale: yes
Male: yes
30Hungary;Germany
12EUCTR2004-004465-15-HU
(EUCTR)
22/07/200511/05/2005A multicentre, open, prospective study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT681 in patients with primary immunodeficiency disease (PID)A multicentre, open, prospective study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT681 in patients with primary immunodeficiency disease (PID) primary immunodeficiency syndrome as congenital agammaglobulinaemia or hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiencies, Wiskott Aldrich syndrome
MedDRA version: 7.0;Level: HLT;Classification code 10036700
Trade Name: Intratect
Product Name: Intratect
Product Code: BT681
Other descriptive name: human normal immunoglobulin (IVIg)
Biotest AGNULLNot RecruitingFemale: yes
Male: yes
50Hungary;Germany
13EUCTR2004-004465-15-DE
(EUCTR)
05/04/200504/02/2005A multicentre, open, prospective study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT681 in patients with primary immunodeficiency disease (PID)A multicentre, open, prospective study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT681 in patients with primary immunodeficiency disease (PID) primary immunodeficiency syndrome as congenital agammaglobulinaemia or hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiencies, Wiskott Aldrich syndrome
MedDRA version: 7.0;Level: HLT;Classification code 10036700
Product Name: Intratect
Product Code: BT681
Other descriptive name: human normal immunoglobulin (IVIg)
Biotest AGNULLNot RecruitingFemale: yes
Male: yes
50Hungary;Germany
14NCT00168012
(ClinicalTrials.gov)
September 200412/9/2005Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 in Patients With Primary Immunodeficiencies (PID)An Open Study to Evaluate the Safety and Efficacy of IVIG-F10 in Patients With Primary Immunodeficiency Diseases (PID)Agammaglobulinemia;IgG Deficiency;Common Variable ImmunodeficiencyDrug: Immunoglobulins Intravenous (Human)CSL BehringNULLCompleted3 Years70 YearsBoth42Phase 3NULL