Immunoglobulin (DrugBank: -)
3 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 | 23 |
| 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 | 78 |
| 63 | 特発性血小板減少性紫斑病 | 28 |
| 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 | NCT04625153 (ClinicalTrials.gov) | December 2020 | 6/11/2020 | RC18 in Patients With Relapsing Remitting Multiple Sclerosis:a Phase II Trial | RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection in Patients With Relapsing Remitting Multiple Sclerosis:a Phase II Trial | Multiple Sclerosis, Relapsing-Remitting | Biological: RC18 160mg;Biological: RC18 240mg | RemeGen | NULL | Not yet recruiting | 18 Years | 55 Years | All | 18 | Phase 2 | NULL |
| 2 | EUCTR2019-001549-42-GB (EUCTR) | 27/03/2020 | 03/02/2020 | Stem cell transplantation versus disease modifying therapy (alemtuzumab or ocrelizumab) for patients with highly active relapsing remitting MS | A multicentre, randomised controlled trial to evaluate the efficacy of autologous haematopoietic stem cell transplantation versus alemtuzumab or ocrelizumab in relapsing remitting multiple sclerosis. - StarMS | Highly active relapsing remitting multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cyclophosphamide INN or Proposed INN: Cyclophosphamide monohydrate INN or Proposed INN: Cyclophosphamide monohydrate Product Name: Filgrastim INN or Proposed INN: Filgrastim Trade Name: Thymoglobuline Product Name: Thymoglobuline INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin Trade Name: Alemtuzumab Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Product Name: Lenograstim INN or Proposed INN: Lenograstim Trade Name: Ocrelizumab Product Name: Ocrelizumab | Sheffield Teaching Hospitals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 198 | Phase 3 | United Kingdom | ||
| 3 | NCT03330418 (ClinicalTrials.gov) | September 21, 2017 | 31/10/2017 | A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis Optica Spectrum Disorders | A Phase III Study of RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection for the Treatment of Subjects With Neuromyelitis Optica Spectrum Disorders. | Neuromyelitis Optica Spectrum Disorders | Biological: Placebo;Biological: RC18 160 mg | RemeGen | NULL | Recruiting | 18 Years | 65 Years | All | 118 | Phase 3 | China |
| 4 | EUCTR2015-001973-42-PL (EUCTR) | 22/02/2016 | 19/01/2016 | Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS). | An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: Dimethyl Fumarate | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Belgium;Poland;Croatia;Lithuania;Bulgaria;Kuwait | ||
| 5 | EUCTR2015-001973-42-BG (EUCTR) | 11/02/2016 | 02/02/2016 | Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS). | An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis MedDRA version: 19.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Poland;Belgium;Croatia;Lithuania;Bulgaria;Kuwait | |||
| 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 | EUCTR2015-001973-42-LT (EUCTR) | 11/02/2016 | 27/11/2015 | Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS). | An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: Dimethyl Fumarate | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Poland;Belgium;Croatia;Lithuania;Bulgaria;Kuwait | ||
| 7 | EUCTR2015-001973-42-HR (EUCTR) | 26/01/2016 | 28/04/2016 | Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS). | An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: Dimethyl Fumarate | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Slovakia;Canada;Poland;Belgium;Lithuania;Turkey;Croatia;Austria;Bulgaria;Kuwait;Sweden | ||
| 8 | EUCTR2015-001973-42-BE (EUCTR) | 17/12/2015 | 23/11/2015 | Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS). | An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: Dimethyl Fumarate | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Czech Republic;Canada;Poland;Belgium;Lithuania;Croatia;Turkey;Austria;Bulgaria;Kuwait | ||
| 9 | NCT02525874 (ClinicalTrials.gov) | August 11, 2015 | 10/7/2015 | Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS). | An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Completed | 18 Years | 65 Years | All | 218 | Phase 3 | United States;Belgium;Bulgaria;Kuwait;Lithuania;Poland;Turkey;Croatia |
| 10 | 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 |
| 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 | EUCTR2012-005086-12-PL (EUCTR) | 07/01/2015 | 16/09/2014 | Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin | Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial | relapsing multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Octagam 50 mg/ml INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Copaxone 20 mg/ml INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms INN or Proposed INN: INTERFERON BETA-1a Trade Name: Betaferon 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1b | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 234 | Phase 3 | Serbia;Hungary;Poland;Ukraine;Austria;Russian Federation;Bulgaria;Germany | ||
| 12 | 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 | ||
| 13 | EUCTR2012-005086-12-BG (EUCTR) | 14/11/2013 | 19/08/2013 | Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin | Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial | relapsing multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Octagam 50 mg/ml INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Copaxone 20 mg/ml INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms Product Name: Rebif 44 micrograms INN or Proposed INN: INTERFERON BETA-1a Trade Name: Betaferon 250 microgram/ml Product Name: Betaferon 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1b Trade Name: Extavia 250 microgram/ml Product Name: Extavia 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1a | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 234 | Phase 3b | Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany | ||
| 14 | EUCTR2012-005086-12-DE (EUCTR) | 12/11/2013 | 01/07/2013 | Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin | Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial | relapsing multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Octagam 50 mg/ml INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Copaxone 20 mg/ml INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms Product Name: Rebif 44 micrograms INN or Proposed INN: INTERFERON BETA-1a Trade Name: Betaferon 250 microgram/ml Product Name: Betaferon 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1b Trade Name: Extavia 250 microgram/ml Product Name: Extavia 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1a | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 216 | Phase 3b | Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany | ||
| 15 | EUCTR2012-005086-12-HU (EUCTR) | 31/07/2013 | 18/06/2013 | Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin | Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial | relapsing multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Octagam 50 mg/ml INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Copaxone 20 mg/ml INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms Product Name: Rebif 44 micrograms INN or Proposed INN: INTERFERON BETA-1a Trade Name: Betaferon 250 microgram/ml Product Name: Betaferon 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1b Trade Name: Extavia 250 microgram/ml Product Name: Extavia 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1a | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 216 | Phase 3b | Hungary;Poland;Austria;Russian Federation;Bulgaria;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 |
| 16 | EUCTR2012-005086-12-AT (EUCTR) | 05/07/2013 | 08/05/2013 | Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin | Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial | relapsing multiple sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Octagam 50 mg/ml INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Copaxone 20 mg/ml INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms Product Name: Rebif 44 micrograms INN or Proposed INN: INTERFERON BETA-1a Trade Name: Betaferon 250 microgram/ml Product Name: Betaferon 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1b Trade Name: Extavia 250 microgram/ml Product Name: Extavia 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1a | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 216 | Phase 3b | Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany | ||
| 17 | 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 |
| 18 | NCT01803867 (ClinicalTrials.gov) | March 2013 | 26/2/2013 | An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis | A Double-Blind, Placebo-Controlled, Single Ascending Intravenous Infusion Study of Recombinant Human Immunoglobulin M (rHIgM22) in Patients With Multiple Sclerosis (MS) | Multiple Sclerosis | Drug: rHIgM22 | Acorda Therapeutics | PRA Health Sciences | Completed | 18 Years | 70 Years | Both | 72 | Phase 1 | United States |
| 19 | EUCTR2010-023560-40-SE (EUCTR) | 23/03/2011 | 21/12/2010 | Blood stem cell transplantation for patients with relapsiong-remitting multiple sclerosis, in whom standard treatment has failed. | Haematopoetic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - MIST | Relapsing-remitting multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Sendoxan Other descriptive name: CYCLOPHOSPHAMIDE MONOHYDRATE Trade Name: Thymoglobuline Other descriptive name: RABBIT HUMAN T LYMPHOCYTE IMMUNOGLOBULIN Trade Name: Neupogen Trade Name: Solu-Medrol | Uppsala l?ns landsting | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | United States;Canada;Brazil;Sweden | |||
| 20 | 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 | |||
| 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 |
| 21 | 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 | |||
| 22 | EUCTR2006-002562-19-IT (EUCTR) | 21/04/2006 | 24/01/2007 | Immunoablation with Cyclophosphamide at high dosage and Rabbit antithymoglobulin followed by autologous hematopoietic stem cell transplantation in severe multiple sclerosis - LIGHT | Immunoablation with Cyclophosphamide at high dosage and Rabbit antithymoglobulin followed by autologous hematopoietic stem cell transplantation in severe multiple sclerosis - LIGHT | VERIFICARE Patients with multiple sclerosis, age between 18 and 50 MedDRA version: 6.1;Level: PT;Classification code 10028245 | Trade Name: L04AA04 - IMMUNOGLOBULINA ANTITIMOCITARIA (DI CONIGLIO) IMMUNOGLOBULINA DI CONIGLIO ANTITIMOCITI UMANI THYMOGLOBULINE Product Name: Thymoglobuline INN or Proposed INN: Antithymocyte Trade Name: Endoxan - ciclofosfamide Product Name: Endoxan INN or Proposed INN: Cyclophosfamide | Dipartimento di Neuroscienze Oftalmologia e Genetica DINOG - Universita di Genova | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Italy | |||
| 23 | EUCTR2008-005773-35-IT (EUCTR) | 15/01/2013 | AUTOLOUGUS STEM CELLS TRANSPLANTATION AFTER LINFOCYTE DEPLETION AS A NEW THERAPY FOR THE AGGRESSIVE AND DRUG RESISTANT FORMS OF MULTIPLE SLEROSIS IN THE ADULTS AND CHILDREN. - AUTOLOUGUS STEM CELLS TRANSPLANTATION IN SM | AUTOLOUGUS STEM CELLS TRANSPLANTATION AFTER LINFOCYTE DEPLETION AS A NEW THERAPY FOR THE AGGRESSIVE AND DRUG RESISTANT FORMS OF MULTIPLE SLEROSIS IN THE ADULTS AND CHILDREN. - AUTOLOUGUS STEM CELLS TRANSPLANTATION IN SM | MULTIPLE SCLEROSIS MedDRA version: 15.1;Level: LLT;Classification code 10028053;Term: MS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: ENDOXAN BAXTER INN or Proposed INN: Cyclophosphamide Trade Name: FLUDARA INN or Proposed INN: Fludarabine Trade Name: THYMOGLOBULINE INN or Proposed INN: Antithymocyte immunoglobulin (rabbit) Trade Name: MABTHERA INN or Proposed INN: Rituximab | AZIENDA OSPEDALIERA DI PADOVA | NULL | NA | Female: yes Male: yes | Phase 1 | Italy |
| 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 | EUCTR2020-002438-34-DK (EUCTR) | 19/08/2020 | 11/06/2020 | Fampridine for treatment of functional disability in patients with immune mediated polyneuropathy | Fampridine for treatment of residual neurological deficits in patients treated with immunoglobulins for chronic inflammatory demyelinating polyneuropathy | Chronic inflammatory demyelinating polyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10072650;Term: CIDP;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampyra INN or Proposed INN: FAMPRIDINE | Department of Neurology, Odense University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | Denmark | ||
| 2 | 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 |
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | NCT03864185 (ClinicalTrials.gov) | March 28, 2019 | 19/2/2019 | The Evaluation of Efficacy and Safety of Rituximab in Refractory CIDP Patients With IgG4 Autoantibodies | The Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients With Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical Trial | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) | Biological: Rituximab (genetical recombination);Other: Placebo | Nagoya University | Japan Agency for Medical Research and Development;Zenyaku Kogyo Co., Ltd. | Active, not recruiting | 12 Years | N/A | All | 25 | Phase 2 | 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 |
| 6 | JPRN-jRCT2041180037 | 28/03/2019 | 31/01/2019 | RECIPE Trial | The Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical Trial - RECIPE Trial | Chronic Inflammatory Demyelinating Polyneuropathy Chronic Inflammatory Demyelinating Polyneuropathy | CIDP patients with positive IgG4 autoantibody (CNTN-1 or NF-155): Administer 375 mg/m2 of rituximab (genetical recombination) or placebo IV infusion once weekly for 4 doses. CIDP patients with negative IgG4 autoantibody (CNTN-1 and NF-155): Administer 375 mg/m2 of rituximab (genetical recombination) IV infusion once weekly for 4 doses. | Iijima Masahiro | NULL | Not Recruiting | >= 12age old | Not applicable | Both | 25 | Phase 2 | Japan |
| 7 | JPRN-UMIN000035753 | 2019/03/28 | 02/02/2019 | The Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical Trial | The Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical Trial - RECIPE Trial | Chronic Inflammatory Demyelinating Polyneuropathy | CIDP patients with positive IgG4 autoantibody (CNTN-1 or NF-155): Administer 375 mg/m2 of rituximab (genetical recombination) IV infusion once weekly for 4 doses. CIDP patients with positive IgG4 autoantibody (CNTN-1 or NF-155): Administer placebo IV infusion once weekly for 4 doses. CIDP patients with negative IgG4 autoantibody (CNTN-1 and NF-155): Administer 375 mg/m2 of rituximab (genetical recombination) IV infusion once weekly for 4 doses. | Nagoya University Hospital | Zenyaku Kogyo Co., Ltd. | Complete: follow-up continuing | 12years-old | Not applicable | Male and Female | 25 | Phase 2 | Japan |
| 8 | 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 | ||
| 9 | EUCTR2017-002024-24-DK (EUCTR) | 08/09/2017 | 19/06/2017 | Systematic reduction in dosage of subcutanoeus immunoglobulin in patients with chronic inflammatory neuropathy | Randomized, cohort study of standardized reduction of subcutaneous immunoglobulin treatment in patients with chronic inflammatory demyelinating polyneuropathy | Chronic inflammatory demyelinating polyneuroapthy MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000014567;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gammanorm Product Name: Gammanorm INN or Proposed INN: Immunoglobulin Other descriptive name: HUMAN IMMUNOGLOBULIN G Trade Name: Hizentra Product Name: Hizentra INN or Proposed INN: Immunoglobulin Other descriptive name: HUMAN IMMUNOGLOBULIN G Trade Name: Subcuvia Product Name: Subcuvia INN or Proposed INN: Immunoglobulin Other descriptive name: HUMAN IMMUNOGLOBULIN G | Aarhus Unversity Hospital | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 4 | Denmark | ||
| 10 | EUCTR2015-005443-14-BG (EUCTR) | 07/09/2017 | 30/05/2017 | Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy. | Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. | Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP) MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: IMMUNOGLOBULIN G | Octapharma Pharmazeutika Produktionsges.m.b.H. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden | ||
| 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 | EUCTR2015-005443-14-SE (EUCTR) | 29/06/2017 | 07/04/2017 | Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy. | Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. | Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP) MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: IMMUNOGLOBULIN G | Octapharma Pharmazeutika Produktionsges.m.b.H. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden | ||
| 12 | EUCTR2015-005443-14-DK (EUCTR) | 01/06/2017 | 06/04/2017 | Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy. | Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. | Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP) MedDRA version: 19.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: IMMUNOGLOBULIN G | Octapharma Pharmazeutika Produktionsges.m.b.H. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Australia;Denmark;Russian Federation;Bulgaria;Germany;Sweden | ||
| 13 | EUCTR2015-005443-14-CZ (EUCTR) | 01/06/2017 | 12/04/2017 | Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy. | Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. | Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP) MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: IMMUNOGLOBULIN G | Octapharma Pharmazeutika Produktionsges.m.b.H. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden | ||
| 14 | EUCTR2015-005443-14-PL (EUCTR) | 16/05/2017 | 13/05/2017 | Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy. | Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. | Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP) MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: IMMUNOGLOBULIN G | Octapharma Pharmazeutika Produktionsges.m.b.H. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden | ||
| 15 | EUCTR2015-005443-14-HU (EUCTR) | 12/05/2017 | 07/04/2017 | Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy. | Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy. | Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP) MedDRA version: 19.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: IMMUNOGLOBULIN G | Octapharma Pharmazeutika Produktionsges.m.b.H. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | Czech Republic;Hungary;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden | ||
| 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 | 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 |
| 17 | EUCTR2013-005558-31-DE (EUCTR) | 10/08/2016 | 08/07/2016 | Exstension of the international study on efficacy and safety of I10E in CIDP patients | International, multicentre, efficacy and safety study of I10E in themaintenance treatment of patients with Chronic InflammatoryDemyelinating Polyradiculoneuropathy: Extension of PRISM studyI10E-1302 - PRISM 2 | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 19.0;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: IQYMUNE Product Name: Human normal 10% immunoglobulin for intravenous administrationn Product Code: I10 INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | France;Poland;Spain;Turkey;Tunisia;Germany;Italy;United Kingdom | ||
| 18 | EUCTR2013-005557-73-DE (EUCTR) | 10/08/2016 | 08/07/2016 | An international study on efficacy and safety of I10E in CIDP patients | An international, multicentre, efficacy and safety study of I10E ininitial and maintenance treatment of patients with ChronicInflammatory Demyelinating Polyradiculoneuropathy - PRISM | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 19.0;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: IQYMUNE Product Name: human normal immunoglobulin for intravenous administration Product Code: I10 INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 3 | France;Poland;Spain;Turkey;Tunisia;Germany;Italy;United Kingdom | ||
| 19 | 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 | |||
| 20 | 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 |
| 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 |
| 21 | 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 | ||
| 22 | EUCTR2013-005558-31-FR (EUCTR) | 23/07/2015 | 26/06/2015 | Extension of the international study on efficacy and safety of I10E in CIDP patients | International, multicentre, efficacy and safety study of I10E in themaintenance treatment of patients with Chronic InflammatoryDemyelinating Polyradiculoneuropathy: Extension of PRISM studyI10E-1302 - PRISM 2 | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 18.0;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] | Product Name: Human normal 10% immunoglobulin for intravenous administrationn Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | France;Morocco;Mexico;Spain;Turkey;Germany;Tunisia;Italy;United Kingdom | ||
| 23 | EUCTR2011-003448-28-PL (EUCTR) | 07/07/2015 | 06/05/2015 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 19.0;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan | ||
| 24 | EUCTR2011-003448-28-EE (EUCTR) | 11/06/2015 | 14/05/2015 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan | ||
| 25 | EUCTR2011-003448-28-LT (EUCTR) | 09/06/2015 | 21/04/2015 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.0;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;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 |
| 26 | 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 | ||
| 27 | EUCTR2013-004157-24-CZ (EUCTR) | 12/03/2015 | 24/03/2014 | Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP) | Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.0;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) Other descriptive name: Hizentra® | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Netherlands;Germany;Italy;Japan | ||
| 28 | 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 | |
| 29 | EUCTR2013-005558-31-ES (EUCTR) | 18/02/2015 | 16/12/2014 | Exstension of the international study on efficacy and safety of I10E in CIDP patients | International, multicentre, efficacy and safety study of I10E in themaintenance treatment of patients with Chronic InflammatoryDemyelinating Polyradiculoneuropathy: Extension of PRISM studyI10E-1302 - PRISM 2 | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 17.1;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] | Product Name: Human normal 10% immunoglobulin for intravenous administrationn Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | France;Morocco;Mexico;Spain;Turkey;Germany;Tunisia;Italy;United Kingdom | ||
| 30 | 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 |
| 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 |
| 31 | EUCTR2013-005558-31-IT (EUCTR) | 26/01/2015 | 20/05/2015 | Extension of the international study on efficacy and safety of I10E in CIDP patients | International, multicentre, efficacy and safety study of I10E in the maintenance treatment of patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy: Extension of PRISM studyI10E-1302 - PRISM 2 | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 18.0;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] | Product Name: : immunoglobulina umana normale 10% per somministrazione endovenosa Product Code: I10E INN or Proposed INN: immunoglobulina umana normale per somministrazione endovenosa Other descriptive name: IMMUNOGLOBULINA UMANA NORMALE per somministrazione endovenosa | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | France;Morocco;Mexico;Spain;Turkey;Germany;United Kingdom;Italy | ||
| 32 | EUCTR2013-005557-73-ES (EUCTR) | 03/12/2014 | 27/08/2014 | An international study on efficacy and safety of I10E in CIDP patients | An international, multicentre, efficacy and safety study of I10E ininitial and maintenance treatment of patients with ChronicInflammatory Demyelinating Polyradiculoneuropathy - PRISM | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 17.0;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] | Product Name: human normal immunoglobulin for intravenous administration Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 3 | France;Morocco;Mexico;Spain;Turkey;Germany;Tunisia;Italy;United Kingdom | ||
| 33 | EUCTR2013-004157-24-NL (EUCTR) | 02/12/2014 | 20/03/2014 | Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP) | Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) Other descriptive name: Hizentra® | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Germany;Netherlands;Italy;Japan | ||
| 34 | EUCTR2013-004157-24-IT (EUCTR) | 01/10/2014 | 21/02/2014 | Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP) | Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 16.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) Other descriptive name: Hizentra® | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Israel;Netherlands;Germany;Japan;Italy | ||
| 35 | EUCTR2013-005557-73-IT (EUCTR) | 30/09/2014 | 27/08/2014 | An international study on efficacy and safety of I10E in CIDP patients | An international, multicentre, efficacy and safety study of I10E ininitial and maintenance treatment of patients with ChronicInflammatory Demyelinating Polyradiculoneuropathy - PRISM | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 17.0;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] | Product Name: human normal immunoglobulin for intravenous administration Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 3 | France;Morocco;Mexico;Spain;Turkey;Germany;Tunisia;United Kingdom;Italy | ||
| 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 |
| 36 | EUCTR2013-005557-73-FR (EUCTR) | 24/09/2014 | 26/06/2015 | An international study on efficacy and safety of I10E in CIDP patients | An international, multicentre, efficacy and safety study of I10E ininitial and maintenance treatment of patients with ChronicInflammatory Demyelinating Polyradiculoneuropathy - PRISM | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 18.0;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] | Product Name: human normal immunoglobulin for intravenous administration Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | LFB BIOTECHNOLOGIES | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | France;Morocco;Mexico;Spain;Turkey;Tunisia;Italy;United Kingdom | |||
| 37 | 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 | ||||
| 38 | NCT02465359 (ClinicalTrials.gov) | September 2014 | 12/12/2014 | Subcutaneous Immunoglobulin for CIDP | A Study of Subcutaneous Immunoglobulin as Chronic Treatment for Patients With Chronic Inflammatory Demyelinating Polyneuropathy | Chronic Inflammatory Demyelinating Polyneuropathy | Drug: Immune Globulin Subcutaneous (Human) | University of South Florida | CSL Behring | Unknown status | 18 Years | 80 Years | All | 20 | N/A | United States |
| 39 | JPRN-JapicCTI-142472 | 04/8/2014 | 13/03/2014 | Phase 3 study of GGS in multifocal motor neuropathy (MMN) | Open-label, uncontrolled, before-and-after study of GGS in multifocal motor neuropathy (MMN) (Phase 3 study) | Multifocal motor neuropathy (MMN) | Intervention name : Freeze-Dried Sulfonated Human Normal Immunoglobulin (GGS) INN of the intervention : - Dosage And administration of the intervention : Intravenous drip infusion Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Teijin Pharma Limited | NULL | complete | 20 | 74 | BOTH | 5 | Phase 3 | Japan |
| 40 | NCT02027701 (ClinicalTrials.gov) | July 30, 2014 | 3/1/2014 | Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Multicenter, Open-label Extension Study to Investigate the Long-term Safety and Efficacy of IgPro20 in Maintenance Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Subjects Completing Study IgPro20_3003 | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP);Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | Biological: IgPro20 | CSL Behring | NULL | Completed | 18 Years | N/A | All | 82 | Phase 3 | United States;Australia;Canada;Czechia;France;Germany;Italy;Japan;Netherlands;Spain;United Kingdom;Czech Republic;Finland |
| 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 |
| 41 | EUCTR2013-004157-24-DE (EUCTR) | 05/06/2014 | 25/02/2014 | Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP) | Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 19.0;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) Other descriptive name: Hizentra® | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Netherlands;Germany;Italy;Japan | ||
| 42 | EUCTR2013-004157-24-GB (EUCTR) | 30/04/2014 | 18/02/2014 | Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP) | Multicenter, open-label extension study to investigate the long-term safety and efficacy of IgPro20 in maintenance treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in subjects completing study IgPro20_3003 | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Netherlands;Germany;Italy;Japan;United Kingdom | |||
| 43 | EUCTR2013-004157-24-ES (EUCTR) | 23/04/2014 | 27/02/2014 | Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP) | Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 16.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) Other descriptive name: Hizentra® | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Israel;Netherlands;Germany;Italy;Japan | ||
| 44 | EUCTR2013-004157-24-FI (EUCTR) | 04/04/2014 | 19/03/2014 | Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP) | Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 17.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) Other descriptive name: Hizentra® | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Netherlands;Germany;Italy;Japan | ||
| 45 | JPRN-JapicCTI-142471 | 10/3/2014 | 13/03/2014 | Phase 3 study of GGS in chronic inflammatory demyelinating polyneuropathy (CIDP) | Open-label, uncontrolled, before-and-after study of GGS in chronic inflammatory demyelinating polyneuropathy (CIDP) (Phase 3 study) | Chronic inflammatory demyelinating polyneuropathy(CIDP) | Intervention name : Freeze-Dried Sulfonated Human Normal Immunoglobulin (GGS) INN of the intervention : - Dosage And administration of the intervention : Intravenous drip infusion Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Teijin Pharma Limited | NULL | complete | 20 | 74 | BOTH | 30 | 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 |
| 46 | NCT02111590 (ClinicalTrials.gov) | January 2014 | 9/4/2014 | Immunoglobulin Dosage and Administration Form in CIDP and MMN | The Influence of Immunoglobulin Dosage and Administration on Development of Hemolytic Anemia and Variation on Muscle Strength in Patients With CIDP and MMN | Chronic Inflammatory Demyelinating Polyneuropathy;Multifocal Motor Neuropathy;Hemolytic Anemia | Drug: Immunoglobulins | Rigshospitalet, Denmark | Aarhus University Hospital;Octapharma Pharmazeutika Produktionsges.m.b.H. | Completed | 18 Years | 80 Years | Both | 36 | N/A | Denmark |
| 47 | 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 |
| 48 | 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 | |||
| 49 | 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 | ||
| 50 | 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 | ||
| 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 |
| 51 | EUCTR2013-001428-20-DK (EUCTR) | 06/06/2013 | 06/06/2013 | Study of the effect of subcutaneous administration of immunoglobulin in patients with newly diagnosed chronic inflammatory demyelinating polyradiculoneuropathy | Randomized, single-blind crossover study of subcutaneous immunoglobulin in newly diagnosed patients with chronic inflammatory demyelinating polyradiculoneuropathy | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 16.0;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 normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: Privigen Product Name: Privigen INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | Aarhus University Hospital | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Denmark | |||
| 52 | 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 |
| 53 | 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 |
| 54 | EUCTR2011-003448-28-BE (EUCTR) | 27/09/2012 | 02/04/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan | ||
| 55 | EUCTR2011-003448-28-IT (EUCTR) | 23/08/2012 | 29/03/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallelgroup phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 14.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN | CSL BEHRING GMBH | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Switzerland;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Netherlands;Korea, Republic of | ||
| 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 |
| 56 | EUCTR2011-003448-28-GB (EUCTR) | 23/05/2012 | 29/03/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan | |||
| 57 | EUCTR2011-003448-28-AT (EUCTR) | 18/05/2012 | 16/03/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 14.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Belgium;Australia;Netherlands;Germany;Korea, Republic of | ||
| 58 | EUCTR2011-003448-28-NL (EUCTR) | 11/05/2012 | 14/03/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 17.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan | ||
| 59 | EUCTR2011-003448-28-CZ (EUCTR) | 09/05/2012 | 23/02/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan | ||
| 60 | EUCTR2011-003448-28-ES (EUCTR) | 24/04/2012 | 29/02/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP)-the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 14.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | Hungary;Germany;Switzerland;Netherlands;France;Italy;Austria;Australia;Finland;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Korea, Republic of;Spain;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 |
| 61 | EUCTR2011-003448-28-DE (EUCTR) | 20/04/2012 | 31/01/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 19.0;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan | ||
| 62 | EUCTR2011-003448-28-FI (EUCTR) | 05/04/2012 | 05/03/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 3 | Japan;United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands | ||
| 63 | NCT01545076 (ClinicalTrials.gov) | March 2012 | 1/3/2012 | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20) | Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Phase III Study to Investigate the Efficacy, Safety, and Tolerability of 2 Different Doses of IgPro20 (Subcutaneous Immunoglobulin) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - the PATH Study | Chronic Inflammatory Demyelinating Polyneuropathy;Polyradiculoneuropathy | Biological: IgPro20 (low dose);Biological: Placebo;Biological: IgPro10;Biological: IgPro20 (high dose) | CSL Behring | ICON Clinical Research | Completed | 18 Years | N/A | All | 208 | Phase 3 | United States;Australia;Belgium;Canada;Czechia;Estonia;Finland;France;Germany;Israel;Italy;Japan;Netherlands;Poland;Spain;United Kingdom;Austria;Czech Republic |
| 64 | EUCTR2009-017805-13-CZ (EUCTR) | 14/07/2011 | 22/04/2010 | PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03 | PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03 | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 14.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders | Product Name: NewGam Product Code: NewGam INN or Proposed INN: Immunoglobuline G Other descriptive name: NewGam | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 172 | Phase 2;Phase 3 | Czech Republic;Bulgaria | ||
| 65 | EUCTR2009-017805-13-BG (EUCTR) | 27/01/2011 | 13/12/2010 | Study to evaluate efficacy of human immune globulin in patients with CIDP-chronic neuropathy. | PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMISED, MULTICENTRE, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03 | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 14.0;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] | Product Name: NewGam Product Code: NewGam INN or Proposed INN: Immunoglobuline G Other descriptive name: NewGam | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 172 | Phase 2;Phase 3 | India;Serbia;Czech Republic;Mexico;Poland;Ukraine;Romania;Bulgaria | ||
| 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 |
| 66 | EUCTR2009-017672-24-FI (EUCTR) | 30/11/2010 | 10/09/2010 | This research study will investigate whether the investigational medicine IgPro10 is efficient and safe for patients with chronic inflammatory demyelinating polyneuropathy (CIDP). | A single-arm study to demonstrate the efficacy and safety of Privigen in the treatment of subjects with chronic inflammatory demyelinating polyneuropathy (CIDP) | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 14.0;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Privigen® INN or Proposed INN: Human normal immunoglobulin G (IgG > 98% purity) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 30 | Finland | |||
| 67 | NCT01184846 (ClinicalTrials.gov) | November 2010 | 18/8/2010 | Study of Efficacy and Safety of Privigen in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy | A Single-arm Study to Demonstrate the Efficacy and Safety of Privigen in the Treatment of Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Chronic Inflammatory Demyelinating Polyneuropathy | Biological: 10% liquid formulation of human immunoglobulin | CSL Behring | NULL | Completed | 18 Years | N/A | All | 31 | Phase 3 | Belgium;Finland;France;Germany;Poland |
| 68 | EUCTR2009-017672-24-BE (EUCTR) | 13/09/2010 | 07/07/2010 | A single-arm study to demonstrate the efficacy and safety of Privigen in the treatment of subjects with chronic inflammatory demyelinating polyneuropathy (CIDP) | A single-arm study to demonstrate the efficacy and safety of Privigen in the treatment of subjects with chronic inflammatory demyelinating polyneuropathy (CIDP) | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 13.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders | Trade Name: Privigen® INN or Proposed INN: Human normal immunoglobulin G (IgG > 98% purity) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | Finland;Belgium | ||
| 69 | EUCTR2009-017805-13-RO (EUCTR) | 08/09/2010 | 15/07/2010 | PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03 | PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03 | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 12.1;Level: LLT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy | Product Name: NewGam Product Code: NewGam INN or Proposed INN: Immunoglobuline G Other descriptive name: NewGam | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 172 | Phase 2;Phase 3 | Czech Republic;Romania;Bulgaria | ||
| 70 | EUCTR2009-013841-27-DK (EUCTR) | 17/12/2009 | 27/10/2009 | A Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multofocl Motor Neuropathy - IGIV, 10% MMN Trial | A Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multofocl Motor Neuropathy - IGIV, 10% MMN Trial | Multifocal motor neuropathy MedDRA version: 12.0;Level: LLT;Classification code 10065579;Term: Multifocal motor neuropathy | Trade Name: KIOVIG 100 mg/ml solution for infusion Product Name: IGIV, 10% Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Baxter Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 40 | 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 |
| 71 | EUCTR2007-000710-37-GB (EUCTR) | 10/04/2008 | 15/02/2008 | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 2 | Germany;Italy;United Kingdom | |||
| 72 | EUCTR2007-000710-37-DE (EUCTR) | 10/12/2007 | 10/09/2007 | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 10 | United Kingdom;Germany;Italy | |||
| 73 | NCT00701662 (ClinicalTrials.gov) | November 2007 | 18/6/2008 | A Study of Purified Human Antibodies Administered Subcutaneously to Patients With Multifocal Motor Neuropathy (MMN) | A Multicentre Study of Subcutaneous Immunoglobulin (SCIG) in Patients With Multifocal Motor Neuropathy (MMN) | Multifocal Motor Neuropathy (MMN) | Biological: Vivaglobin | CSL Behring | NULL | Completed | 18 Years | N/A | All | 8 | Phase 2 | Italy;Switzerland;United Kingdom;Germany |
| 74 | EUCTR2007-000710-37-IT (EUCTR) | 04/10/2007 | 12/02/2008 | A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN) - ND | A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN) - ND | Maintenance treatment with subcutaneous immunoglobulin (Vivaglobin) in patients with MMN. MedDRA version: 9.1;Level: LLT;Classification code 10036105;Term: Polyneuropathy | Trade Name: Vivaglobin INN or Proposed INN: Immunoglobulins, normal human, for extravascular adm. | CSL Behring AG | NULL | Not Recruiting | Female: yes Male: yes | 10 | United Kingdom;Germany;Italy | |||
| 75 | 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 | |||
| 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 |
| 76 | 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 |
| 77 | NCT01349270 (ClinicalTrials.gov) | June 2004 | 5/5/2011 | Randomized Open-label Trial to Compare Efficacy and Tolerance of Corticosteroids and IVIg | Multicentre 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 up | Demyelinating Polyneuropathy | Drug: Immunoglobulin perfusion;Drug: Prednisone | Centre Hospitalier Universitaire de Saint Etienne | Laboratoire français de Fractionnement et de Biotechnologies | Completed | 18 Years | 80 Years | Both | 40 | Phase 3 | France |
| 78 | 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 | EUCTR2015-003653-17-CZ (EUCTR) | 07/05/2018 | 09/09/2016 | An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) | An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) | Chronic primary immune thrombocytopenia (ITP) MedDRA version: 20.0;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | Hungary;Czech Republic;Spain;Bulgaria;Germany | |||
| 2 | EUCTR2015-003653-17-DE (EUCTR) | 27/01/2017 | 17/06/2016 | An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) | An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) | Chronic primary immune thrombocytopenia (ITP) MedDRA version: 19.0;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | Czech Republic;Hungary;Spain;Bulgaria;Germany | |||
| 3 | EUCTR2015-003653-17-BG (EUCTR) | 27/01/2017 | 21/11/2016 | An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) | An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) | Chronic primary immune thrombocytopenia (ITP) MedDRA version: 20.0;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | Czech Republic;Hungary;Spain;Bulgaria;Germany | |||
| 4 | NCT02859909 (ClinicalTrials.gov) | November 2016 | 25/7/2016 | This Clinical Study is to Test Efficacy and Safety of BT595 in Chronic Primary Immune Thrombocytopenia (ITP) | An Open Label, Prospective, Randomized, Multicenter Study Investigating Clinical Efficacy and Safety of the Human Normal Immunoglobulin for Intravenous Administration BT595 in Patients With Chronic Primary Immune Thrombocytopenia (ITP) | Immune Thrombocytopenia | Biological: BT595 | Biotest | Syneos Health | Completed | 18 Years | 75 Years | All | 34 | Phase 3 | Bulgaria;Czechia;Germany;Hungary;Serbia;Spain |
| 5 | EUCTR2015-003653-17-HU (EUCTR) | 07/09/2016 | 19/07/2016 | An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) | An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) | Chronic primary immune thrombocytopenia (ITP) MedDRA version: 19.0;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | Czech Republic;Hungary;Spain;Bulgaria;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 | EUCTR2015-003653-17-ES (EUCTR) | 06/09/2016 | 11/08/2016 | An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) | An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) | Chronic primary immune thrombocytopenia (ITP) MedDRA version: 19.0;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | Czech Republic;Hungary;Spain;Bulgaria;Germany | |||
| 7 | EUCTR2009-014589-24-FR (EUCTR) | 12/06/2013 | 27/09/2011 | NA | Prospective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NEWGAM) in Primary Immune Thrombocytopenia - NGAM-02 | Primary Immune Thrombocytopenia (ITP) MedDRA version: 14.0;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NewGAM Product Code: NewGAM Other descriptive name: IMMUNOGLOBULIN G | Octapharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 95 | Phase 3 | France;Czech Republic;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;India | ||
| 8 | EUCTR2011-001354-29-ES (EUCTR) | 24/09/2012 | 19/07/2012 | An open-label, multicentre efficacy and safety study of a human immunoglobulin (project code I10E) in patients with primary Immune ThrombocytoPenia (ITP) | An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP) | ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminology proposed by an international working group (Rodeghiero et al, 2009) MedDRA version: 14.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE | LFB BIOTECHNOLOGIES | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | France;Belarus;Hungary;Poland;Spain;Ukraine;Russian Federation;Germany;Italy | |||
| 9 | EUCTR2012-000796-16-PL (EUCTR) | 17/08/2012 | 25/06/2012 | Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune thrombocytopenia | PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA | Primary Immune Thrombocytopenia (ITP) MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Octagam 10% Product Name: Octagam 10% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | Czech Republic;Poland;Bulgaria | ||
| 10 | EUCTR2012-000796-16-BG (EUCTR) | 18/07/2012 | 22/05/2012 | Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune thrombocytopenia | PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA | Primary Immune Thrombocytopenia (ITP) MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Octagam 10% Product Name: Octagam 10% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | Czech Republic;Poland;Bulgaria | ||
| 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 | EUCTR2012-000796-16-DE (EUCTR) | 09/07/2012 | 20/03/2012 | Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune thrombocytopenia | PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA | Primary Immune Thrombocytopenia (ITP) MedDRA version: 14.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Octagam 10% Product Name: Octagam 10% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | Germany;Czech Republic;Poland;Bulgaria | ||
| 12 | EUCTR2012-000796-16-CZ (EUCTR) | 29/05/2012 | 04/04/2012 | Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune thrombocytopenia | PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA | Primary Immune Thrombocytopenia (ITP) MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Octagam 10% Product Name: Octagam 10% INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: IMMUNOGLOBULIN G | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | Czech Republic;Poland;Bulgaria;Germany | ||
| 13 | EUCTR2009-014589-24-BG (EUCTR) | 04/01/2012 | 13/09/2011 | NA | Prospective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NEWGAM) in Primary Immune Thrombocytopenia - NGAM-02 | Primary Immune Thrombocytopenia (ITP) MedDRA version: 16.0;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NewGAM Product Code: NewGAM INN or Proposed INN: Immunoglobulin Other descriptive name: IMMUNOGLOBULIN G | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 95 | Phase 3 | France;Czech Republic;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Germany;India | ||
| 14 | EUCTR2011-000263-27-BG (EUCTR) | 14/11/2011 | 25/08/2011 | An non-blinded, mulicenter study to investigate the mechanisms which are involved in the interaction of red blood cells with the study drug IgPro10 in patients with chronic immune thrombocytopenic purpura (ITP) who have shown signs of hemolysis (a breakdown or destruction of red blood cells). | An open-label, prospective, multicenter study to investigate the specificity of in vivo antibody binding to red blood cells in subjects with chronic immune thrombocytopenic purpura (ITP) treated with IgPro10 (Privigen®) who have shown signs of hemolysis. - Privigen® in ITP | Chronic immune thrombocytopenic purpura (ITP) MedDRA version: 16.0;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Privigen® Product Name: Privigen® INN or Proposed INN: Human Normal Immunoglobulin G (IgG > 98% purity) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Serbia;Poland;Turkey;Bulgaria | |||
| 15 | EUCTR2011-001354-29-IT (EUCTR) | 09/11/2011 | 07/03/2012 | An efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP) | An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP) | ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteriaadopting the new consensus terminology proposed by an internationalworking group (Rodeghiero et al, 2009) MedDRA version: 14.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: human normal immunoglobulin for intravenous use Product Code: I10E INN or Proposed INN: NA Other descriptive name: NA | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 40 | Hungary;Spain;Ukraine;Russian Federation;Germany;Italy | |||
| 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 | EUCTR2011-001354-29-HU (EUCTR) | 09/11/2011 | 12/10/2011 | An open-label, multicentre efficacy and safety study of a human immunoglobulin (project code I10E) in patients with primary Immune ThrombocytoPenia (ITP) | An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP) | ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminology proposed by an international working group (Rodeghiero et al, 2009) MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 40 | France;Hungary;Spain;Poland;Ukraine;Russian Federation;Germany;Italy | |||
| 17 | EUCTR2011-001354-29-DE (EUCTR) | 12/10/2011 | 06/10/2011 | An open-label, multicentre efficacy and safety study of a human immunoglobulin (project code I10E) in patients with primary Immune ThrombocytoPenia (ITP) | An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP) | ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminology proposed by an international working group (Rodeghiero et al, 2009) MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE Other descriptive name: human Immunoglobulin | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 40 | France;Hungary;Spain;Poland;Ukraine;Russian Federation;Germany;Italy | |||
| 18 | NCT01349790 (ClinicalTrials.gov) | October 2011 | 5/5/2011 | Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NewGam) in Primary Immune Thrombocytopenia | Prospective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NewGam) in Primary Immune Thrombocytopenia | Primary Thrombocytopenia | Drug: NewGam | Octapharma | NULL | Completed | 18 Years | 65 Years | All | 40 | Phase 3 | Germany |
| 19 | EUCTR2009-014589-24-DE (EUCTR) | 22/09/2011 | 12/04/2011 | NA | Prospective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NEWGAM) in Primary Immune Thrombocytopenia - NGAM-02 | Primary Immune Thrombocytopenia (ITP) MedDRA version: 15.0;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NewGAM Product Code: NewGAM INN or Proposed INN: Immunglobulin Other descriptive name: IMMUNOGLOBULIN G | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 95 | Phase 3 | France;Czech Republic;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;India | ||
| 20 | EUCTR2009-014589-24-CZ (EUCTR) | 02/09/2011 | 26/04/2011 | NA | Prospective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NEWGAM) in Primary Immune Thrombocytopenia - NGAM-02 | Primary Immune Thrombocytopenia (ITP) MedDRA version: 15.0;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NewGAM Product Code: NewGAM INN or Proposed INN: immunoglobulin Other descriptive name: IMMUNOGLOBULIN G | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 95 | Phase 3 | France;Czech Republic;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;India | ||
| 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 |
| 21 | EUCTR2011-000263-27-PL (EUCTR) | 22/07/2011 | 08/06/2011 | An non-blinded, mulicenter study to investigate the mechanisms which are involved in the interaction of red blood cells with the study drug IgPro10 in patients with chronic immune thrombocytopenic purpura (ITP) who have shown signs of hemolysis (a breakdown or destruction of red blood cells). | An open-label, prospective, multicenter study to investigate the specificity of in vivo antibody binding to red blood cells in subjects with chronic immune thrombocytopenic purpura (ITP) treated with IgPro10 (Privigen®) who have shown signs of hemolysis. - Privigen® in ITP | Chronic immune thrombocytopenic purpura (ITP) MedDRA version: 15.0;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Privigen® Product Name: Privigen® INN or Proposed INN: Human Normal Immunoglobulin G (IgG > 98% purity) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring LLC | NULL | Not Recruiting | Female: yes Male: yes | 150 | Serbia;Poland;Turkey;Bulgaria | |||
| 22 | EUCTR2008-001597-33-NL (EUCTR) | 18/06/2009 | 29/05/2008 | Development of chronic disease in newly diagnosed Idiopathic Thrombocytopenic Purpura of Childhood. A randomized controlled study on the influence of treatment with intravenous gammaglobulin on the course of the disease. - The TIKI study : Treatment with or without IVIG in Kids with acute ITP | Development of chronic disease in newly diagnosed Idiopathic Thrombocytopenic Purpura of Childhood. A randomized controlled study on the influence of treatment with intravenous gammaglobulin on the course of the disease. - The TIKI study : Treatment with or without IVIG in Kids with acute ITP | Acute Idiopathic Thrombocytopenic Purpura (ITP) in children MedDRA version: 14.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 10005329 - Blood and lymphatic system disorders | Trade Name: Nanogam Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | University Medical Center Utrecht | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Netherlands | ||
| 23 | NCT00504075 (ClinicalTrials.gov) | September 2007 | 18/7/2007 | A Study to Find How Safe and Effective GAMMAPLEX® is in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP) | A Phase III, Multicenter, Open-Label Study To Evaluate the Efficacy and Safety of GAMMAPLEX® in Chronic Idiopathic Thrombocytopenic Purpura | Chronic Idiopathic Thrombocytopenic Purpura | Biological: Gammaplex, intravenous immunoglobulin | Bio Products Laboratory | NULL | Completed | 18 Years | 70 Years | All | 35 | Phase 3 | United States;Argentina;India |
| 24 | EUCTR2005-003552-35-FR (EUCTR) | 10/05/2007 | 29/12/2006 | Clinical study to evaluate the efficacity and safety of octagam®10% in idiopathic thrombocytopenic purpura in adults - N/A | Clinical study to evaluate the efficacity and safety of octagam®10% in idiopathic thrombocytopenic purpura in adults - N/A | the medical condition which have to be investigated is the evolution of platelets counts in adults with a idiopathic thrombocytopenic purpura, with less than 20 10^9 platelets/L and treated by Octagam10% (immunoglobulines). | Product Name: Octagam® 10% INN or Proposed INN: Human Immunoglobulin | Octapharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 116 | Czech Republic;Germany;France | |||
| 25 | EUCTR2005-003552-35-DE (EUCTR) | 28/03/2006 | 13/01/2006 | Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/A | Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/A | Idiopathic thrombocytopenic purpura, in adults actively bleeding or at high risk bleeding. MedDRA version: 7.0;Level: LLT;Classification code 10021245 | Product Name: Octagam® 10% INN or Proposed INN: Human Immunoglobulin G | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 116 | Czech Republic;Germany;France | |||
| 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 |
| 26 | EUCTR2005-003552-35-AT (EUCTR) | 20/02/2006 | 16/01/2006 | Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/A | Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/A | Idiopathic thrombocytopenic purpura, in adults actively bleeding or at high risk bleeding. MedDRA version: 7.0;Level: LLT;Classification code 10021245 | Product Name: Octagam® 10% INN or Proposed INN: Human Immunoglobulin G | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 116 | France;Czech Republic;Austria;Germany | |||
| 27 | NCT00151840 (ClinicalTrials.gov) | October 2001 | 8/9/2005 | Efficacy and Safety of IVIG-L in ITP Patients | Efficacy and Safety of IVIG-L (Human Normal Immunoglobulin for Intravenous Use)in Idiopathic Thrombocytopenic Purpura (ITP)Patients | Purpura, Thrombocytopenic, Idiopathic | Drug: IVIG-L | Sanquin | NULL | Completed | 18 Years | N/A | Both | 20 | Phase 3 | Poland |
| 28 | EUCTR2011-005586-21-Outside-EU/EEA (EUCTR) | 07/12/2011 | A research study to determine if an experimental IVIG product, Gammaplex®, is safe, tolerable, and effective when given to patients who have Idiopathic Thrombocytopenic Purpura | A Phase III, Multicenter, Open-Label Study To Evaluate the Efficacy and Safety of GAMMAPLEX® in Chronic Idiopathic Thrombocytopenic Purpura - n/a | Idiopathic thrombocytopenic purpura. MedDRA version: 14.0;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Gammaplex Product Name: Gammaplex Product Code: n/a INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | Bio Products Laboratory Limited | NULL | NA | Female: yes Male: yes | 35 | Phase 3 | Argentina;India;United States |