65. 原発性免疫不全症候群 Primary immunodeficiency Clinical trials / Disease details
臨床試験数 : 500 / 薬物数 : 614 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 217
| 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 | NCT03974178 (ClinicalTrials.gov) | September 29, 2019 | 23/5/2019 | Efficacy and Safety of Fexinidazole in Patients With Human African Trypanosomiasis (HAT) Due to Trypanosoma Brucei Rhodesiense | Efficacy and Safety of Fexinidazole in Patients With Human African Trypanosomiasis (HAT) Due to Trypanosoma Brucei Rhodesiense: a Multicentre, Open-label Clinical Trial | Trypanosoma Brucei Rhodesiense; Infection | Drug: Fexinidazole | Drugs for Neglected Diseases | European and Developing Countries Clinical Trials Partnership (EDCTP) | Completed | 6 Years | N/A | All | 45 | Phase 2/Phase 3 | Malawi;Uganda |
| 2 | NCT03025789 (ClinicalTrials.gov) | November 17, 2016 | 11/11/2016 | Fexinidazole in Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage | An Open-label Study Assessing Effectiveness, Safety and Compliance With Fexinidazole in Patients With Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage | Trypanosomiasis, African;Sleeping Sickness;Trypanosomiasis; Gambian | Drug: Fexinidazole | Drugs for Neglected Diseases | Sanofi | Completed | 6 Years | N/A | All | 174 | Phase 3 | Congo, The Democratic Republic of the;Guinea |
| 3 | NCT02571062 (ClinicalTrials.gov) | March 2015 | 24/6/2015 | Bioequivalence Study - Reference Clinical Fexinidazole Tablet Versus Proposed Market Formulation | A Bioequivalence Study of the Reference Clinical Fexinidazole Tablet vs Proposed Market Formulation in Healthy Male Volunteers of African Sub-Saharan Origin:an Open-label,Randomized,Two-treatment,Single Dose,Replicate Design,Fed Condition | Trypanosomiasis, African | Drug: Fexinidazole | Drugs for Neglected Diseases | NULL | Completed | 18 Years | 45 Years | Male | 30 | Phase 1 | France |
| 4 | NCT02498782 (ClinicalTrials.gov) | July 2014 | 20/8/2014 | Study to Evaluate Fexinidazole Dosing Regimens for the Treatment of Adult Patients With Chagas Disease | Phase 2, Randomized, Multicenter, Placebo-controlled, Safety and Efficacy Study to Evaluate Six Oral Fexinidazole Dosing Regimens for the Treatment of Adult Patients With Chronic Indeterminate Chagas Disease. | Chagas Disease;Trypanosomiasis, South American;South American Trypanosomiasis;Disease, Chagas | Drug: Fexinidazole;Drug: Placebo | Drugs for Neglected Diseases | NULL | Recruiting | 18 Years | 50 Years | Both | 140 | Phase 2 | Bolivia |
| 5 | NCT02184689 (ClinicalTrials.gov) | May 3, 2014 | 19/6/2014 | Efficacy and Safety of Fexinidazole in Children at Least 6 Years Old and Weighing Over 20 kg With Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: a Prospective, Multicentre, Open Study, plug-in to the Pivotal Study | Efficacy and Safety of Fexinidazole in Children at Least 6 Years Old and Weighing Over 20 kg With Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: a Prospective, Multicentre, Open Study, plug-in to the Pivotal Study | Human African Trypanosomiasis (HAT) | Drug: fexinidazole | Drugs for Neglected Diseases | NULL | Completed | 6 Years | 14 Years | All | 125 | Phase 2/Phase 3 | Congo, The Democratic Republic of the |
| 6 | NCT02169557 (ClinicalTrials.gov) | April 30, 2014 | 15/5/2014 | Efficacy and Safety of Fexinidazole in Patients With Stage 1 or Early Stage 2 Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: a Prospective, Multicentre, Open-label Cohort Study, plug-in to the Pivotal Study | Efficacy and Safety of Fexinidazole in Patients With Stage 1 or Early Stage 2 Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: a Prospective, Multicentre, Open-label Cohort Study, plug-in to the Pivotal Study | Human African Trypanosomiasis (HAT) | Drug: Fexinidazole | Drugs for Neglected Diseases | NULL | Completed | 15 Years | N/A | All | 230 | Phase 2/Phase 3 | Congo, The Democratic Republic of the |
| 7 | NCT01685827 (ClinicalTrials.gov) | October 2012 | 12/9/2012 | Pivotal Study of Fexinidazole for Human African Trypanosomiasis in Stage 2 | Efficacy and Safety of Fexinidazole Compared to Nifurtimox-Eflornithine Combination Therapy (NECT) in Patients With Late-stage Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: Pivotal, Non-inferiority, Multicentre, Randomised, Open-label Study | Human African Trypanosomiasis (HAT);Sleeping Sickness | Drug: Fexinidazole;Drug: Nifurtimox;Drug: Eflornithine | Drugs for Neglected Diseases | NULL | Completed | 15 Years | N/A | All | 394 | Phase 2/Phase 3 | Central African Republic;Congo, The Democratic Republic of the;Congo |
| 8 | NCT01483170 (ClinicalTrials.gov) | September 2011 | 29/11/2011 | Multiple Dose Study to Evaluate Security, Tolerance and Pharmacokinetic of Fexinidazole (Drug Candidate for Human African Trypanosomiasis) Administered With a Loading Dose and With Food | Double-blind, Placebo Controlled, Randomized Multiple Ascending Dose Study in Fed Conditions for Ten Days Dosing Regimen With a Loading Dose to Evaluate the Safety, the Tolerability and the Pharmacokinetics of Oral Fexinidazole in 36 Healthy Male Sub-Saharan Volunteers. | Trypanosomiasis, African | Drug: Tablets Fexinidazole;Drug: Placebo | Drugs for Neglected Diseases | NULL | Terminated | 18 Years | 45 Years | Male | 30 | Phase 1 | France |
| 9 | NCT00982904 (ClinicalTrials.gov) | September 2009 | 22/9/2009 | Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the Fexinidazole | Randomized, Double-blind, Placebo-controlled Study of the Tolerability, and Pharmacokinetics of Fexinidazole After Single and Repeated Oral Ascending Doses, Completed by a Comparative Bioavailability Study of an Oral Suspension Versus a Tablet and an Exploratory Assessment of Food Effect, in Healthy Male Volunteers | Human African Trypanosomiasis | Drug: Fexinidazole/Placebo | Drugs for Neglected Diseases | Sanofi | Completed | 18 Years | 45 Years | Male | 108 | Phase 1 | France |