Api (DrugBank: -)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 231 | α1-アンチトリプシン欠乏症 | 3 |
| 299 | 嚢胞性線維症 | 1 |
| 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 | 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 | ||
| 2 | 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 | ||
| 3 | NCT00460096 (ClinicalTrials.gov) | March 2007 | 12/4/2007 | Phase II/III Study of an Alpha-1 Proteinase Inhibitor (Kamada-API) in Individuals With Alpha-1 Antitrypsin Deficiency | Randomized Double-Blind Comparison of an Alpha-1 Proteinase Inhibitor (Kamada API) With a Currently Marketed API Product in Individuals With Alpha-1 Antitrypsin Deficiency | Alpha 1-Antitrypsin Deficiency | Drug: Kamada-API | Kamada, Ltd. | NULL | Completed | 18 Years | N/A | Both | 50 | Phase 2;Phase 3 | United States |
| 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 | NCT01347190 (ClinicalTrials.gov) | April 2011 | 3/5/2011 | Safety and Tolerability Study of Liquid Alpha1 Proteinase Inhibitor (API) in Subjects With Cystic Fibrosis | A Double Blind, Randomized, Placebo Controlled, Single Dose, Phase I Study of the Safety and Tolerability of Alpha1 Proteinase Inhibitor (Human) Inhalation Solution (CR002) in Subjects With Cystic Fibrosis | Cystic Fibrosis | Biological: CR002 Liquid API;Biological: Placebo | CSL Behring | NULL | Completed | 18 Years | 65 Years | Both | 25 | Phase 1 | Bulgaria;Hungary;Poland;United Kingdom |