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 | NCT04275479 (ClinicalTrials.gov) | January 10, 2020 | 10/2/2020 | Diabetes/ Endocrine Surveillance in SDS | Endocrine Diabetes Screening in Patients With Shwachman-Diamond Syndrome DIABETES/ ENDOCRINE SURVEILLANCE IN SDS | Shwachman-Diamond Syndrome | Diagnostic Test: Oral Glucose Tolerance Test;Other: Modified Oral Glucose Tolerance Test;Other: Modified Mixed Meal Tolerance Test;Device: Continuous Glucose Monitor;Other: Food Diary;Other: Medical History Questionnaires | Washington University School of Medicine | Shwachman Diamond Syndrome Foundation;Barnes-Jewish Hospital | Recruiting | 3 Years | N/A | All | 60 | United States | |
| 2 | NCT03939533 (ClinicalTrials.gov) | October 17, 2019 | 3/5/2019 | Study to Monitor Subcutaneous Human Immunoglobulin Administered at Modified Dosing Regimens in Patients With Primary Immunodeficiency Diseases | Clinical Phase 3 Study to Monitor the Safety, Tolerability, and Efficacy of Subcutaneous Human Immunoglobulin (CUTAQUIG®) Administered at Modified Dosing Regimens in Patients With Primary Immunodeficiency Diseases | Primary Immune Deficiency Disorder | Drug: CUTAQUIG | Octapharma | NULL | Completed | 2 Years | 75 Years | All | 64 | Phase 3 | United States |
| 3 | NCT03512314 (ClinicalTrials.gov) | January 24, 2018 | 9/4/2018 | Therapeutic Use of Tadekinig Alfa in NLRC4 Mutation and XIAP Deficiency as Open Label Extension | Open-label Extension Study With Tadekinig Alfa (r-hIL-18BP) to Monitor Safety and Tolerability in Patients With IL-18 Driven Monogenic Autoinflammatory Conditions: NLRC4 Mutation and XIAP Deficiency | XIAP Deficiency;NLRC4-MAS | Drug: Tadekinig alfa | AB2 Bio Ltd. | NULL | Recruiting | N/A | N/A | All | 10 | Phase 3 | United States;Canada;Germany |
| 4 | NCT03907241 (ClinicalTrials.gov) | March 1, 2016 | 7/12/2018 | CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES, INCLUDING (BUT NOT LIMITED TO) THOSE WHO HAVE COMPLETED THE SCGAM-01 TRIAL | Title for SCGAM-03: CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES WHO HAVE COMPLETED THE SCGAM-01 TRIAL Title for SCGAM-03 in Canada: CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES, INCLUDING (BUT NOT LIMITED TO) THOSE WHO HAVE COMPLETED THE SCGAM-01 TRIAL | Primary Immunodeficiency | Drug: Octanorm 16.5% | Octapharma | NULL | Completed | 2 Years | 75 Years | All | 27 | Phase 3 | United States;Canada |
| 5 | NCT02627300 (ClinicalTrials.gov) | March 2016 | 3/12/2015 | Study of Octanorm Subcutaneous IG in Patients With Primary Immunodeficiency Diseases Who Have Completed the SCGAM-01 Trial | Clinical Phase III Study to Monitor the Safety, Tolerability and Efficacy of Subcutaneous Human Immunoglobulin (Octanorm) in Patients With Primary Immunodeficiency Diseases Who Have Completed the SCGAM-01 Trial | Primary Immunodeficiency Disease | Drug: Octanorm 16.5% | Octapharma | NULL | Completed | N/A | N/A | All | 21 | Phase 3 | United States;Canada |
| 6 | EUCTR2018-003199-10-DE (EUCTR) | 04/10/2018 | OPEN-LABEL STUDY: THERAPEUTIC USE OF TADEKINIG ALFA IN NLRC4 MUTATION AND XIAP DEFICIENCY | Open-label extension study with Tadekinig alfa (r-hIL-18BP) to monitor safety and tolerability in patients with IL-18 driven monogenic autoinflammatory conditions: NLRC4 mutation and XIAP deficiency | NLRC4 mutation XIAP deficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tadekinig alfa Product Code: r-hIL-18BP INN or Proposed INN: Tadekinig alfa Other descriptive name: TADEKINIG ALFA | AB2 Bio Ltd. | NULL | NA | Female: yes Male: yes | 10 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Canada;Germany |