API-AAT, AD00370, ARC-AAT, API drug Substance ( 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2

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_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
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Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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size
PhaseCountries
1EUCTR2016-000917-59-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
2EUCTR2016-000917-59-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