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 | EUCTR2018-004407-39-DE (EUCTR) | 26/06/2020 | 05/02/2020 | A safety and efficacy study of N-Acetyl-L-Leucine on Ataxia-Telangiectasia. | Effects of N-Acetyl-L-Leucine on Ataxia-Telangiectasia (A-T): A multinational, multicenter, open-label, rater-blinded Phase II study. | Ataxia-Telangiectasia (A-T) MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: N-Acetyl-L-Leucine Product Code: IB1001 INN or Proposed INN: N-Acetyl-L-leucine Other descriptive name: 2(S)-(ACETYLAMINO)-4-METHYLPENTANOIC ACID Product Name: N-Acetyl-L-Leucine Product Code: IB1001 INN or Proposed INN: N-Acetyl-L-leucine Other descriptive name: 2(S)-(ACETYLAMINO)-4-METHYLPENTANOIC ACID | IntraBio Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 39 | Phase 2 | United States;Spain;Germany;United Kingdom | ||
| 2 | NCT03759678 (ClinicalTrials.gov) | January 8, 2020 | 27/11/2018 | N-Acetyl-L-Leucine for Ataxia-Telangiectasia (A-T) | Effects of N-Acetyl-L-Leucine on Ataxia-Telangiectasia (A-T): A Multinational, Multicenter, Open-label, Rater-blinded Phase II Study | Ataxia Telangiectasia;Louis Bar Syndrome | Drug: IB1001 | IntraBio Inc | NULL | Recruiting | 6 Years | N/A | All | 39 | Phase 2 | United States;Germany;Spain;United Kingdom |
| 3 | EUCTR2018-004407-39-GB (EUCTR) | 18/09/2019 | 06/08/2019 | A safety and efficacy study of N-Acetyl-L-Leucine on Ataxia-Telangiectasia | Effects of N-Acetyl-L-Leucine on Ataxia-Telangiectasia (A-T): A multinational, multicenter, open-label, rater-blinded Phase II study. - IB1001-203 | To demonstrate that N-Acetyl-L-Leucine is effective in improving symptoms, functioning, and quality of life in patients with Ataxia-Telangiectasia (A-T);Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: N-Acetyl-L-Leucine Product Code: IB 1001 Other descriptive name: N-Acetyl-L-Leucine | IntraBio Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 39 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Germany;United Kingdom |