231. α1−アンチトリプシン欠乏症 Alpha-1-antitrypsin deficiency Clinical trials / Disease details
臨床試験数 : 93 / 薬物数 : 77 - (DrugBank : 8) / 標的遺伝子数 : 10 - 標的パスウェイ数 : 36
| 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 | NCT02900183 (ClinicalTrials.gov) | October 2016 | 9/9/2016 | Safety, Tolerability and Effect of ARC-AAT Injection on Circulating and Intrahepatic Alpha-1 Antitrypsin Levels | An Open-Label, Multi-dose, Phase 2 Study to Determine the Safety, Tolerability and Effect on Circulating and Intrahepatic Alpha-1 Antitrypsin Levels of ARC-AAT as Evidenced by Changes in Liver Biopsy in Patients With Alpha-1 Antitrypsin Deficiency (AATD) | Alpha-1 Antitrypsin Deficiency | Drug: ARC-AAT Injection | Arrowhead Pharmaceuticals | NULL | Withdrawn | 18 Years | 75 Years | All | 0 | Phase 2 | Canada;Ireland;Italy;Sweden |
| 2 | EUCTR2016-000917-59-SE (EUCTR) | 04/08/2016 | 08/06/2016 | A clinical trial to assess the safety and effects of a novel medicine intended for the treatment of patients with liver disease due to Alpha-1 Antitrypsin Deficiency (AATD) | An Open-Label, Multi-dose, Phase 2 Study to Determine the Safety, Tolerability and Effect on Circulating and Intrahepatic Alpha-1 Antitrypsin Levels of ARC-AAT as evidenced by changes in liver biopsy in Patients with Alpha-1 Antitrypsin Deficiency (AATD) | Alpha-1 Antitrypsin Deficiency related liver disease MedDRA version: 19.0;Level: PT;Classification code 10001806;Term: Alpha-1 anti-trypsin deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ARC-AAT Injection Product Code: ARC-AAT INN or Proposed INN: API-AAT Other descriptive name: API-AAT, AD00370, ARC-AAT, API drug Substance Product Name: ARC-AAT Injection Product Code: ARC-AAT INN or Proposed INN: API-AAT Other descriptive name: API-AAT, AD00370, ARC-AAT, API drug Substance Product Name: ARC-AAT Injection Product Code: ARC-AAT INN or Proposed INN: API-AAT Other descriptive name: API-AAT, AD00370, ARC-AAT, API drug Substance | Arrowhead Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | Canada;Ireland;Sweden | ||
| 3 | EUCTR2016-000917-59-IE (EUCTR) | 29/06/2016 | 13/04/2016 | A clinical trial to assess the safety and effects of a novel medicine intended for the treatment of patients with liver disease due to Alpha-1 Antitrypsin Deficiency (AATD) | An Open-Label, Multi-dose, Phase 2 Study to Determine the Safety, Tolerability and Effect on Circulating and Intrahepatic Alpha-1 Antitrypsin Levels of ARC-AAT as evidenced by changes in liver biopsy in Patients with Alpha-1 Antitrypsin Deficiency (AATD) | Alpha-1 Antitrypsin Deficiency related liver disease MedDRA version: 19.1;Level: PT;Classification code 10001806;Term: Alpha-1 anti-trypsin deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ARC-AAT Injection Product Code: ARC-AAT INN or Proposed INN: API-AAT Other descriptive name: API-AAT, AD00370, ARC-AAT, API drug Substance | Arrowhead Pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | Canada;Ireland;Sweden | ||
| 4 | NCT02363946 (ClinicalTrials.gov) | February 2015 | 2/2/2015 | A Study of ARC-AAT in Healthy Volunteer Subjects and Patients With Alpha-1 Antitrypsin Deficiency (AATD) | A Double-Blind, Placebo-Controlled, Dose-Escalating, Phase 1 Study to Determine the Safety, Tolerability, Pharmacokinetics and Effect of Circulating Alpha-1 Antitrypsin Levels of ARC-AAT in Healthy Volunteer Subjects and in Patients With Alpha-1 Antitrypsin Deficiency (AATD) | Alpha-1 Antitrypsin Deficiency | Drug: ARC-AAT Injection;Other: Placebo | Arrowhead Pharmaceuticals | NULL | Terminated | 18 Years | 70 Years | All | 65 | Phase 1 | Australia;Germany;Netherlands;United Kingdom |