ARC-AAT Injection ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
231Alpha-1-antitrypsin deficiency4

231. Alpha-1-antitrypsin deficiency


Clinical trials : 89 Drugs : 89 - (DrugBank : 16) / Drug target genes : 35 - Drug target pathways : 47
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
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