65. 原発性免疫不全症候群 Primary immunodeficiency Clinical trials / Disease details
臨床試験数 : 482 / 薬物数 : 653 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 212
| 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 | NCT04842643 (ClinicalTrials.gov) | April 27, 2021 | 11/4/2021 | A Phase 3, Open-label, Non-controlled, Multi-dose, Extension Study to Evaluate the Long-term Safety and Tolerability of IGSC, 20% in Japanese Subjects With Primary Immunodeficiency Disease (PID) | A Phase 3, Open-label, Non-controlled, Multi-dose, Extension Study to Evaluate the Long-term Safety and Tolerability of IGSC, 20% in Japanese Subjects With Primary Immunodeficiency Disease (PID) | Primary Immunodeficiency Disease | Biological: IGSC 20% infusion | Takeda | NULL | Recruiting | 2 Years | N/A | All | 10 | Phase 3 | Japan |
| 2 | NCT04566692 (ClinicalTrials.gov) | January 5, 2021 | 22/9/2020 | A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency | A Multi-center, Single-Sequence, Open-label Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Subjects and Loading/Maintenance Dosing in Treatment-Naïve Subjects With Primary Immunodeficiency | Primary Immunodeficiency | Biological: IGSC 20% | Grifols Therapeutics LLC | NULL | Active, not recruiting | 6 Years | 75 Years | All | 33 | Phase 4 | United States |
| 3 | NCT03814798 (ClinicalTrials.gov) | December 2019 | 22/1/2019 | Study Evaluating IGSC 20% Flexible Dosing in Treatment-Experienced and Treatment-Naive Subjects With Primary Immunodeficiency | A Multicenter, Randomized, Cross-over, Open-label Study to Evaluate IGSC 20% Flexible Dosing Including Daily Push Dosing In Treatment-Experienced Subjects With Primary Immunodeficiency (PI) and Evaluation of Loading/Maintenance IGSC 20% in Treatment-Naïve Subjects With PI | Primary Immunodeficiency | Biological: IGSC 20% daily push versus every 2 weeks pump;Biological: IGSC 20% daily push versus once a week pump;Biological: IGSC 20% daily push versus 2 times per week pump;Biological: IGSC 20% 150 mg/kg | Grifols Therapeutics LLC | NULL | Withdrawn | 2 Years | 75 Years | All | 0 | Phase 3 | United States |
| 4 | EUCTR2015-003290-15-HU (EUCTR) | 01/09/2017 | 12/05/2017 | A Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency | A Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency - GTI1503 | Primary Immunodeficiency (PI) diseases MedDRA version: 20.0;Level: PT;Classification code 10061598;Term: Immunodeficiency;System Organ Class: 10021428 - Immune system disorders MedDRA version: 20.0;Level: LLT;Classification code 10045792;Term: Unspecified disorder of immune mechanism;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) Product Code: IGSC 20% INN or Proposed INN: Immune Globulin Subcutaneous (Human), 20%, Caprylate/Chromatography Purified | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Hungary;Poland;Spain;Australia;Germany;United Kingdom;Sweden | ||
| 5 | EUCTR2015-003290-15-DE (EUCTR) | 12/07/2016 | 16/03/2016 | A Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency | A Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency - GTI1503 | Primary Immunodeficiency (PI) diseases MedDRA version: 20.0;Level: PT;Classification code 10061598;Term: Immunodeficiency;System Organ Class: 10021428 - Immune system disorders MedDRA version: 20.0;Level: LLT;Classification code 10045792;Term: Unspecified disorder of immune mechanism;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) Product Code: IGSC 20% INN or Proposed INN: Immune Globulin Subcutaneous (Human), 20%, Caprylate/Chromatography Purified | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Hungary;Czech Republic;Poland;Spain;Australia;Germany;United Kingdom;Sweden | ||
| 6 | EUCTR2015-003290-15-FR (EUCTR) | 29/06/2016 | 28/09/2018 | A Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency | A Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency - GTI1503 | Primary Immunodeficiency (PI) diseases MedDRA version: 20.0;Level: PT;Classification code 10061598;Term: Immunodeficiency;System Organ Class: 10021428 - Immune system disorders MedDRA version: 20.1;Level: LLT;Classification code 10045792;Term: Unspecified disorder of immune mechanism;System Organ Class: 10021428 - Immune system disorders MedDRA version: 20.0;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) Product Code: IGSC 20% INN or Proposed INN: Immune Globulin Subcutaneous (Human), 20%, Caprylate/Chromatography Purified | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Hungary;Czech Republic;Poland;Spain;Germany;United Kingdom | ||
| 7 | EUCTR2015-003290-15-CZ (EUCTR) | 22/06/2016 | 01/02/2016 | A Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency | A Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency - GTI1503 | Primary Immunodeficiency (PI) diseases MedDRA version: 20.0;Level: PT;Classification code 10061598;Term: Immunodeficiency;System Organ Class: 10021428 - Immune system disorders MedDRA version: 20.1;Level: LLT;Classification code 10045792;Term: Unspecified disorder of immune mechanism;System Organ Class: 10021428 - Immune system disorders MedDRA version: 20.0;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) Product Code: IGSC 20% INN or Proposed INN: Immune Globulin Subcutaneous (Human), 20%, Caprylate/Chromatography Purified | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Hungary;Czech Republic;Poland;Spain;Germany;United Kingdom | ||
| 8 | NCT02806986 (ClinicalTrials.gov) | June 2016 | 3/6/2016 | Efficacy, Pharmacokinetics, Safety, and Tolerability of IGSC 20% in Subjects With Primary Immunodeficiency | A Multi-Center, Open-Label, Single-Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects With Primary Immunodeficiency | Primary Immunodeficiency | Biological: IGSC 20% | Grifols Therapeutics LLC | NULL | Completed | 2 Years | 75 Years | All | 61 | Phase 3 | Australia;Czechia;France;Germany;Hungary;Poland;Spain;Sweden;United Kingdom;Czech Republic |
| 9 | EUCTR2015-003290-15-GB (EUCTR) | 12/05/2016 | 13/01/2016 | A Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency | A Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency - GTI1503 | Primary Immunodeficiency (PI) diseases MedDRA version: 20.0;Level: PT;Classification code 10061598;Term: Immunodeficiency;System Organ Class: 10021428 - Immune system disorders MedDRA version: 20.0;Level: LLT;Classification code 10045792;Term: Unspecified disorder of immune mechanism;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) Product Code: IGSC 20% INN or Proposed INN: Immune Globulin Subcutaneous (Human), 20%, Caprylate/Chromatography Purified | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | France;Hungary;Czech Republic;Spain;Poland;Australia;Germany;United Kingdom;Sweden | ||
| 10 | EUCTR2015-003290-15-ES (EUCTR) | 12/04/2016 | 22/02/2016 | A Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency | A Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency - GTI1503 | Primary Immunodeficiency (PI) diseases MedDRA version: 18.1;Level: PT;Classification code 10061598;Term: Immunodeficiency;System Organ Class: 10021428 - Immune system disorders MedDRA version: 18.1;Level: LLT;Classification code 10045792;Term: Unspecified disorder of immune mechanism;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) Product Code: IGSC 20% INN or Proposed INN: Immune Globulin Subcutaneous (Human), 20%, Caprylate/Chromatography Purified | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Hungary;Czech Republic;Poland;Spain;Germany;United Kingdom | ||
| 11 | NCT02604810 (ClinicalTrials.gov) | January 2016 | 6/11/2015 | Safety and Pharmacokinetics of IGSC 20% in Subjects With Primary Immunodeficiency | An Open-label, Multi-center Study to Evaluate the Safety and Pharmacokinetics of IGSC 20% Administered for 6 Months in Subjects With Primary Immunodeficiency | Primary Immunodeficiency | Biological: IGIV-C 10%;Biological: IGSC 20% | Grifols Therapeutics LLC | NULL | Completed | 2 Years | 75 Years | All | 53 | Phase 3 | United States;Canada |
| 12 | EUCTR2015-003290-15-PL (EUCTR) | 15/12/2016 | A Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency | A Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency - GTI1503 | Primary Immunodeficiency (PI) diseases MedDRA version: 20.1;Level: LLT;Classification code 10045792;Term: Unspecified disorder of immune mechanism;System Organ Class: 10021428 - Immune system disorders MedDRA version: 20.0;Level: PT;Classification code 10061598;Term: Immunodeficiency;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) Product Code: IGSC 20% INN or Proposed INN: Immune Globulin Subcutaneous (Human), 20%, Caprylate/Chromatography Purified | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | France;Hungary;Czech Republic;Spain;Poland;Germany;United Kingdom |