Intravenous immunoglobulin (DrugBank: -)
8 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 13 | 多発性硬化症／視神経脊髄炎 | 5 |
| 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 | 18 |
| 35 | 天疱瘡 | 1 |
| 38 | スティーヴンス・ジョンソン症候群 | 1 |
| 39 | 中毒性表皮壊死症 | 1 |
| 49 | 全身性エリテマトーデス | 1 |
| 51 | 全身性強皮症 | 13 |
| 309 | 進行性ミオクローヌスてんかん | 1 |
| 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 | NCT02398994 (ClinicalTrials.gov) | March 2015 | 23/3/2015 | A Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin Versus Standard Therapy for Transverse Myelitis | A Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin (IVIg) Versus Standard Therapy for the Treatment of Transverse Myelitis in Adults and Children | Myelitis, Transverse;Neuromyelitis Optica | Drug: Intravenous Methylprednisolone;Drug: Intravenous Immunoglobulin | Guy's and St Thomas' NHS Foundation Trust | King'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 Lothian | Terminated | 1 Year | N/A | Both | 2 | Phase 3 | United Kingdom |
| 2 | EUCTR2014-002335-34-GB (EUCTR) | 30/10/2014 | 23/10/2014 | Intravenous immunoglobulin vs standard therapy for treatment of transverse myelitis | A 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 Trust | NULL | Not Recruiting | Female: yes Male: yes | 0 | Phase 3 | United Kingdom | ||
| 3 | NCT01845584 (ClinicalTrials.gov) | May 2013 | 26/4/2013 | Phase II Clinical Trial of NPB-01 in Patients With Anti-aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorder Not Provided Adequate Effect of Therapy to Steroids Plus Therapy. | NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Anti-aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorder Not Provided Adequate Effect of Therapy to Steroids Plus Therapy. | Neuromyelitis Optica Spectrum Disorder | Drug: NPB-01 | Nihon Pharmaceutical Co., Ltd | NULL | Completed | 20 Years | N/A | All | 7 | Phase 2 | Japan |
| 4 | EUCTR2008-004579-22-DE (EUCTR) | 31/03/2009 | 07/11/2008 | 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 efefct of Octagam 5% in subjects with relapsing/remitting Multiple Sclerosis | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Austria;Germany | |||
| 5 | EUCTR2008-004579-22-AT (EUCTR) | 14/10/2008 | 15/09/2008 | 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) | 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Austria |
| 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 | NCT04589299 (ClinicalTrials.gov) | June 4, 2020 | 9/9/2020 | Subcutaneous Immunoglobulin in De-novo CIDP (SIDEC) | Randomized, Parallel Study of Subcutaneous Versus Intravenous Immunoglobulin in Treatment-naïve Patients With Chronic Inflammatory Demyelinating Polyneuropathy | CIDP - Chronic Inflammatory Demyelinating Polyneuropathy | Biological: Immunoglobulin | University of Aarhus | Rigshospitalet, Denmark;Aarhus University Hospital;Odense University Hospital;Aalborg University Hospital | Recruiting | 18 Years | N/A | All | 60 | Phase 4 | Denmark |
| 2 | EUCTR2018-003592-34-DK (EUCTR) | 02/08/2019 | 14/03/2019 | Subcutaneous versus intravenous administration of immunoglobulin in newly diagnosed patients with chronic inflammatory neuropathy | Subcutaneous 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 Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 4 | Denmark | ||
| 3 | EUCTR2017-002511-34-GB (EUCTR) | 01/04/2019 | 08/11/2019 | Initial 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: 21.1;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: methylprednisolone Product Name: methylprednisolone Trade Name: sodium chloride 0.9% Product Name: sodium chloride 0.9% | Academic Medical Centre, Amsterdam, NL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 96 | Phase 3 | Netherlands;United Kingdom | ||
| 4 | EUCTR2017-002511-34-NL (EUCTR) | 26/09/2018 | 17/04/2018 | Intravenous 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 Centrum | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 96 | Phase 3 | Netherlands | ||
| 5 | 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 | |||
| 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 |
| 6 | EUCTR2012-001995-12-IT (EUCTR) | 19/05/2015 | 13/03/2013 | 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 Neuropathy | 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 Neuropathy | Multifocal motor neuropathy (MMN) MedDRA version: 15.1;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System 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 BIOTECHNOLOGIES | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 3 | France;Spain;United Kingdom;Italy | ||
| 7 | NCT02414490 (ClinicalTrials.gov) | March 2015 | 13/3/2015 | IVIg Treatment-Related Fluctuations in CIDP Patients Using Daily Grip Strength Measurements | Intravenous Immunoglobulin (IVIg) Treatment-Related Fluctuations in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients Using Daily Grip Strength Measurements (GRIPPER) | Chronic Inflammatory Demyelinating Polyneuropathy | Drug: Intravenous Immunoglobulin | University of Minnesota | BriovaRx Infusion Services;CSL Behring | Completed | 18 Years | 85 Years | All | 30 | United States | |
| 8 | NCT02372149 (ClinicalTrials.gov) | February 2015 | 12/2/2015 | IVIg for Demyelination in Diabetes Mellitus | Treatment With Gamunex 10% Intravenous Immunoglobulin (IVIg) for Patients With Demyelination and Diabetes Mellitus: A Blinded, Placebo-Controlled Crossover Pilot Study | Peripheral Neuropathy;Diabetes Mellitus;Chronic Inflammatory Demyelinating Polyneuropathy | Drug: 10% intravenous immunoglobulin (IVIg);Drug: 0.9% sodium chloride | University of Toronto | University Health Network, Toronto | Recruiting | 18 Years | N/A | Both | 25 | Phase 4 | Canada |
| 9 | EUCTR2013-005363-52-NL (EUCTR) | 10/09/2014 | 27/03/2014 | Intravenous immunoglobulin overtreatment in CIDP | Intravenous 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 Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 10 | NCT01951924 (ClinicalTrials.gov) | December 2013 | 20/9/2013 | LIME 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 Neuropathy | Motor Neuron Disease | Drug: 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 Biotechnologies | TFS Trial Form Support | Completed | 18 Years | 80 Years | Both | 23 | Phase 3 | France;Italy;Spain;United Kingdom |
| 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 |
| 11 | EUCTR2012-001995-12-GB (EUCTR) | 01/08/2013 | 03/06/2013 | 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 Neuropathy | 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 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 BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | France;Spain;Italy;United Kingdom | |||
| 12 | EUCTR2012-001995-12-ES (EUCTR) | 12/07/2013 | 12/07/2013 | 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 Neuropathy | 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 Neuropathy | Multifocal motor neuropathy (MMN) MedDRA version: 16.0;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | 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 BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | France;Spain;United Kingdom | ||
| 13 | EUCTR2012-001995-12-FR (EUCTR) | 03/07/2013 | 04/04/2014 | 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 Neuropathy | 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 Neuropathy | Multifocal motor neuropathy (MMN) MedDRA version: 16.1;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System 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 BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | France;Spain;United Kingdom | ||
| 14 | NCT01824251 (ClinicalTrials.gov) | April 2013 | 1/4/2013 | Phase 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 Polyneuropathy | Drug: NPB-01 | Nihon Pharmaceutical Co., Ltd | NULL | Completed | 20 Years | 100 Years | Both | 49 | Phase 3 | Japan |
| 15 | NCT01827072 (ClinicalTrials.gov) | April 2013 | 1/4/2013 | Phase 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 Neuropathy | Drug: NPB-01 | Nihon Pharmaceutical Co., Ltd | NULL | Completed | 20 Years | 100 Years | Both | 13 | Phase 3 | Japan |
| 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 |
| 16 | EUCTR2005-001136-76-IT (EUCTR) | 09/07/2007 | 07/09/2007 | Double 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 | Double 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. | KEDRION | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Italy | |||
| 17 | NCT00268788 (ClinicalTrials.gov) | August 2005 | 21/12/2005 | Subcutaneous Immunoglobulin Treatment for Multifocal Motor Neuropathy | A Controlled Cross-Over Trial of Subcutaneous Versus Intravenous Immunoglobulin for Multifocal Motor Neuropathy | Multifocal Motor Neuropathy | Drug: Subcutaneous immunoglobulin;Drug: Intravenous immunoglobulin | University of Aarhus | NULL | Completed | 18 Years | 80 Years | Both | 10 | Phase 2 | Denmark |
| 18 | NCT00001287 (ClinicalTrials.gov) | December 1990 | 3/11/1999 | Intravenous 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;Paraproteinemias | Drug: intravenous immunoglobulin (IVIg) | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | N/A | N/A | Both | 60 | Phase 2 | United States |
| 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 | NCT00483119 (ClinicalTrials.gov) | April 2007 | 5/6/2007 | Randomized Trial of IVIg With or Without Cyclophosphamide in Pemphigus | Phase 2 Randomized Trial of IVIg With or Without Cyclophosphamide in Pemphigus | Pemphigus Vulgaris | Drug: intravenous immunoglobulin;Drug: cyclophosphamide | New York University School of Medicine | NULL | Terminated | 18 Years | 85 Years | All | 9 | Phase 2 | United States |
| 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 | NCT01696500 (ClinicalTrials.gov) | October 2012 | 20/9/2012 | Phase III Clinical Trial of NPB-01 in Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids. | NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids. | Stevens-Johnson Syndrome;Toxic Epidermal Necrolysis | Drug: Intravenous immunoglobulin | Nihon Pharmaceutical Co., Ltd | NULL | Completed | 20 Years | N/A | Both | 10 | Phase 3 | Japan |
| 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 | NCT01696500 (ClinicalTrials.gov) | October 2012 | 20/9/2012 | Phase III Clinical Trial of NPB-01 in Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids. | NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids. | Stevens-Johnson Syndrome;Toxic Epidermal Necrolysis | Drug: Intravenous immunoglobulin | Nihon Pharmaceutical Co., Ltd | NULL | Completed | 20 Years | N/A | Both | 10 | Phase 3 | Japan |
| 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 | NCT00230035 (ClinicalTrials.gov) | September 2005 | 28/9/2005 | Lupus Immunosuppressive/Immunomodulatory Therapy or Stem Cell Transplant (LIST) | A Randomized, Open Label, Phase II Multicenter Study of Non-Myeloablative Autologous Transplantation With Auto-CD34+HPC Versus Currently Available Immunosuppressive/Immunomodulatory Therapy for Treatment of Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Procedure: Leukapheresis;Procedure: Non-myeloablative high dose immunosuppressive therapy conditioning (HDIT);Procedure: Autologous CD34+HPC transplantation (HSCT);Procedure: Plasmapheresis;Drug: Rabbit anti-thymocyte globulin;Drug: Methylprednisolone;Drug: Growth colony stimulating factor (G-CSF);Drug: Corticosteroids;Drug: Mycophenolate mofetil;Drug: Azathioprine;Drug: Intravenous immunoglobulin;Drug: Methotrexate;Drug: Rituximab;Drug: Leflunomide | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Withdrawn | 18 Years | 60 Years | Both | 0 | Phase 2 | United States |
| 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 | EUCTR2019-000906-31-DE (EUCTR) | 01/07/2020 | 31/10/2019 | Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc) | A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis | efficacy and safety in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous (IV) administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 2 | United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany | ||
| 2 | EUCTR2019-000906-31-GB (EUCTR) | 22/05/2020 | 29/10/2019 | Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc) | A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis | efficacy and safety in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous (IV) administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 2 | United States;Spain;United Kingdom;Italy;Switzerland;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany | ||
| 3 | EUCTR2019-000906-31-PL (EUCTR) | 31/01/2020 | 06/12/2019 | Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc) | A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis | efficacy and safety in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous (IV) administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 2 | United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Poland;Belgium;Australia;Germany | ||
| 4 | NCT04138485 (ClinicalTrials.gov) | December 20, 2019 | 14/10/2019 | Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc) | A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults With Systemic Sclerosis | Diffuse Cutaneous Systemic Sclerosis | Biological: IgPro10;Biological: Placebo | CSL Behring | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 2 | United States;Argentina;Australia;Belgium;Canada;France;Germany;Italy;Mexico;Poland;Spain;Switzerland;United Kingdom |
| 5 | EUCTR2019-000906-31-ES (EUCTR) | 16/12/2019 | 20/12/2019 | Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc) | A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis | efficacy and safety in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | CSL Behring GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 188 | Phase 2 | United States;Spain;Switzerland;United Kingdom;Italy;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany | |||
| 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 |
| 6 | EUCTR2019-000906-31-FR (EUCTR) | 03/12/2019 | 08/11/2019 | Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc) | A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis | efficacy and safety in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous (IV) administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 2 | United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany | ||
| 7 | NCT04137224 (ClinicalTrials.gov) | September 19, 2019 | 21/10/2019 | Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc) | A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) and IgPro10 (Intravenous Immunoglobulin, Privigen®) in Adults With Systemic Sclerosis (SSc) | Diffuse Cutaneous Systemic Sclerosis | Biological: IgPro20;Biological: IgPro10 | CSL Behring | NULL | Recruiting | 18 Years | N/A | All | 26 | Phase 2 | Australia;France;Germany;Italy;Poland;United Kingdom |
| 8 | EUCTR2018-003149-41-DE (EUCTR) | 16/07/2019 | 20/03/2019 | Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults with Systemic Sclerosis (SSc). | A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in Adults with Systemic Sclerosis (SSc). - n/a | Safety and Pharmacokinetics in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Hizentra Product Name: Human normal immunoglobulin for subcutaneous administration Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 26 | Phase 2 | France;Poland;Australia;Germany;United Kingdom;Italy | ||
| 9 | EUCTR2018-003149-41-FR (EUCTR) | 24/05/2019 | 27/03/2019 | Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults with Systemic Sclerosis (SSc). | A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in Adults with Systemic Sclerosis (SSc). - n/a | Safety and Pharmacokinetics in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | CSL Behring GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 26 | Phase 2 | France;Poland;Australia;Germany;Italy;United Kingdom | |||
| 10 | EUCTR2018-003149-41-GB (EUCTR) | 15/05/2019 | 30/07/2019 | Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults with Systemic Sclerosis (SSc). | A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in Adults with Systemic Sclerosis (SSc). - n/a | Safety and Pharmacokinetics in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Hizentra Product Name: Human normal immunoglobulin for subcutaneous administration Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 26 | Phase 2 | France;Poland;Australia;Germany;Italy;United Kingdom | ||
| 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 |
| 11 | NCT03630211 (ClinicalTrials.gov) | July 31, 2018 | 7/8/2018 | Autologous Stem Cell Transplantation in Patients With Systemic Sclerosis | Autologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Patients With Treatment Resistant Systemic Sclerosis (SSc) | Systemic Sclerosis;Diffuse Sclerosis Systemic;Interstitial Lung Disease;Pulmonary Hypertension | Drug: Cyclophosphamide;Drug: Mesna;Drug: Rituximab;Drug: Alemtuzumab;Drug: Thiotepa;Drug: GM-CSF;Drug: Intravenous immunoglobulin;Radiation: Total Body Irradiation | Paul Szabolcs | NULL | Recruiting | 16 Years | 70 Years | All | 8 | Phase 2 | United States |
| 12 | NCT01785056 (ClinicalTrials.gov) | April 2013 | 28/1/2013 | IVIG Treatment in Systemic Sclerosis | A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Efficacy of Intravenous Immunoglobulin Treatment in Patients With Systemic Sclerosis | Systemic Sclerosis;Diffuse Scleroderma | Biological: Privigen | Georgetown University | CSL Behring | Unknown status | 18 Years | N/A | All | 14 | N/A | United States |
| 13 | NCT00348296 (ClinicalTrials.gov) | July 2006 | 3/7/2006 | Efficacy and Safety Study of GB-0998 for Treatment of Systemic Sclerosis | A Randomized, Double-blind, Placebo-controlled Multi-center Study of GB-0998 for Treatment of Systemic Sclerosis | Scleroderma, Systemic | Drug: High-dose intravenous immunoglobulin (Venoglobulin-IH) | Benesis Corporation | NULL | Completed | 16 Years | N/A | Both | 60 | Phase 3 | Japan |
| 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 | NCT03351569 (ClinicalTrials.gov) | December 9, 2015 | 27/10/2017 | Intravenous Immunoglobulin for Unverricht-Lundborg Disease. | Intravenous Immunoglobulin for Unverricht-Lundborg Disease: Single-patient Trial. | Unverricht-Lundborg Disease | Drug: Intravenous immunoglobulin | Azienda Socio Sanitaria Territoriale di Mantova | NULL | Active, not recruiting | 18 Years | 25 Years | Male | 1 | Phase 3 | NULL |