ARC-AAT ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
231α1−アンチトリプシン欠乏症4

231. α1−アンチトリプシン欠乏症


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.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1NCT02900183
(ClinicalTrials.gov)
October 20169/9/2016Safety, Tolerability and Effect of ARC-AAT Injection on Circulating and Intrahepatic Alpha-1 Antitrypsin LevelsAn 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 DeficiencyDrug: ARC-AAT InjectionArrowhead PharmaceuticalsNULLWithdrawn18 Years75 YearsAll0Phase 2Canada;Ireland;Italy;Sweden
2EUCTR2016-000917-59-SE
(EUCTR)
04/08/201608/06/2016A 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 IncNULLNot RecruitingFemale: yes
Male: yes
12Phase 2Canada;Ireland;Sweden
3EUCTR2016-000917-59-IE
(EUCTR)
29/06/201613/04/2016A 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, IncNULLNot RecruitingFemale: yes
Male: yes
12Phase 2Canada;Ireland;Sweden
4NCT02363946
(ClinicalTrials.gov)
February 20152/2/2015A 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 DeficiencyDrug: ARC-AAT Injection;Other: PlaceboArrowhead PharmaceuticalsNULLTerminated18 Years70 YearsAll65Phase 1Australia;Germany;Netherlands;United Kingdom