ARO-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15

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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PhaseCountries
1EUCTR2018-003385-14-AT
(EUCTR)
28/01/202114/09/2020A 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)A Placebo-Controlled, Multi-dose, Phase 2/3 Study to Determine the Safety, Tolerability and Effect on Liver Histologic Parameters in Response to ARO-AAT in Patients with Alpha-1 Antitrypsin Deficiency (AATD) [SEQUOIA] alpha-1 antitrypsin deficiency (AATD)-associated liver disease
MedDRA version: 23.1;Level: LLT;Classification code 10001806;Term: Alpha-1 anti-trypsin deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ARO-AAT Injection
Product Code: ARO-AAT
INN or Proposed INN: ADS-001
Arrowhead Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2;Phase 3Portugal;United States;Canada;Spain;Ireland;Austria;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
2EUCTR2018-003385-14-DE
(EUCTR)
05/01/202125/05/2020A 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)A Placebo-Controlled, Multi-dose, Phase 2 Study to Determine the Safety, Tolerability and Pharmacodynamic Effect of ARO-AAT in Patients with Alpha-1 Antitrypsin Deficiency (AATD) [SEQUOIA] alpha-1 antitrypsin deficiency (AATD)-associated liver disease
MedDRA version: 23.1;Level: LLT;Classification code 10001806;Term: Alpha-1 anti-trypsin deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ARO-AAT Injection
Product Code: ARO-AAT
INN or Proposed INN: ADS-001
Arrowhead Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 2Portugal;United States;Canada;Spain;Ireland;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
3EUCTR2018-003385-14-GB
(EUCTR)
19/10/202028/06/2019A 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)A Placebo-Controlled, Multi-dose, Phase 2/3 Study to Determine the Safety, Tolerability and Effect on Liver Histologic Parameters in Response to ARO-AAT in Patients with Alpha-1 Antitrypsin Deficiency (AATD) [SEQUOIA] alpha-1 antitrypsin deficiency (AATD)-associated liver disease
MedDRA version: 23.0;Level: LLT;Classification code 10001806;Term: Alpha-1 anti-trypsin deficiency;System Organ Class: 10001806 - Alpha-1 anti-trypsin deficiency;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ARO-AAT Injection
Product Code: ARO-AAT
INN or Proposed INN: ADS-001
Arrowhead Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2;Phase 3United States;Portugal;Canada;Spain;Poland;Ireland;Netherlands;Italy;United Kingdom;Sweden
4EUCTR2018-003385-14-SE
(EUCTR)
31/01/202025/03/2019A 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) [SEQUOIA]A Placebo-Controlled, Multi-dose, Phase 2 Study to Determine the Safety, Tolerability and Pharmacodynamic Effect of ARO-AAT in Patients with Alpha-1 Antitrypsin Deficiency (AATD) [SEQUOIA] alpha-1 antitrypsin deficiency (AATD)-associated liver disease
MedDRA version: 23.1;Level: LLT;Classification code 10001806;Term: Alpha-1 anti-trypsin deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ARO-AAT Injection
Product Code: ARO-AAT
INN or Proposed INN: ADS-001
Arrowhead Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
36Phase 2Portugal;United States;Canada;Spain;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden;Ireland
5NCT03946449
(ClinicalTrials.gov)
December 19, 20198/5/2019Study of ARO-AAT in Patients With Alpha-1 Antitrypsin Deficiency Associated Liver Disease (AATD)A Pilot Open Label, Multi-dose, Phase 2 Study to Assess the Safety and Efficacy of ARO-AAT in Patients With Alpha-1 Antitrypsin Deficiency Associated Liver Disease (AATD)Alpha 1-Antitrypsin DeficiencyDrug: ARO-AAT InjectionArrowhead PharmaceuticalsNULLActive, not recruiting18 Years75 YearsAll16Phase 2Austria;Germany;United Kingdom
6EUCTR2019-000068-86-AT
(EUCTR)
14/11/201912/06/2019A 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)A Pilot Open Label, Multi-dose, Phase 2 Study to Assess the Safety and Efficacy of ARO-AAT in Patients with Alpha-1 Antitrypsin Deficiency Associated Liver Disease (AATD) alpha-1 antitrypsin deficiency (AATD)-associated liver disease
MedDRA version: 23.1;Level: LLT;Classification code 10001806;Term: Alpha-1 anti-trypsin deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ARO-AAT Injection
Product Code: ARO-AAT
INN or Proposed INN: ADS-001
Arrowhead Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
16Phase 2Austria;Germany;United Kingdom
7EUCTR2018-003385-14-NL
(EUCTR)
07/11/201924/07/2019A 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)A Placebo-Controlled, Multi-dose, Phase 2 Study to Determine the Safety, Tolerability and Pharmacodynamic Effect of ARO-AAT in Patients with Alpha-1 Antitrypsin Deficiency (AATD) [SEQUOIA] alpha-1 antitrypsin deficiency (AATD)-associated liver disease
MedDRA version: 23.1;Level: LLT;Classification code 10001806;Term: Alpha-1 anti-trypsin deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ARO-AAT Injection
Product Code: ARO-AAT
INN or Proposed INN: ADS-001
Arrowhead Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 2Portugal;United States;Canada;Spain;Ireland;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden
8EUCTR2018-003385-14-PT
(EUCTR)
04/11/201909/07/2019A 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)A Placebo-Controlled, Multi-dose, Phase 2 Study to Determine the Safety, Tolerability and Pharmacodynamic Effect of ARO-AAT in Patients with Alpha-1 Antitrypsin Deficiency (AATD) [SEQUOIA] alpha-1 antitrypsin deficiency (AATD)-associated liver disease
MedDRA version: 23.1;Level: LLT;Classification code 10001806;Term: Alpha-1 anti-trypsin deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ARO-AAT Injection
Product Code: ARO-AAT
INN or Proposed INN: ADS-001
Arrowhead Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 2United States;Portugal;Canada;Spain;Poland;Ireland;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
9EUCTR2018-003385-14-ES
(EUCTR)
11/09/201911/06/2019A 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)A Placebo-Controlled, Multi-dose, Phase 2/3 Study to Determine the Safety, Tolerability and Effect on Liver Histologic Parameters in Response to ARO-AAT in Patients with Alpha-1 Antitrypsin Deficiency (AATD) alpha-1 antitrypsin deficiency (AATD)-associated liver disease
MedDRA version: 20.1;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: ARO-AAT Injection
Product Code: ARO-AAT
INN or Proposed INN: ADS-001
Arrowhead Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2;Phase 3United States;Portugal;Poland;Spain;Ireland;Netherlands;Italy;Sweden
10EUCTR2018-003385-14-IT
(EUCTR)
05/09/201919/01/2021A Placebo-Controlled, Multi-dose, Phase 2/3 Study to Determine the Safety, Tolerability and Effect on Liver Histologic Parameters in Response to ARO-AAT in Patients with Alpha-1 Antitrypsin Deficiency (AATD).A Placebo-Controlled, Multi-dose, Phase 2/3 Study to Determine the Safety, Tolerability and Effect on Liver Histologic Parameters in Response to ARO-AAT in Patients with Alpha-1 Antitrypsin Deficiency (AATD) - AROAAT2001 Alpha-1 antitrypsin deficiency (AATD)-associated liver disease.
MedDRA version: 23.1;Level: LLT;Classification code 10001806;Term: Alpha-1 anti-trypsin deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ARO-AAT Injection
Product Code: [ARO-AAT]
ARROWHEAD PHARMACEUTICALSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
118Phase 2Portugal;United States;Spain;Poland;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden
11NCT03945292
(ClinicalTrials.gov)
August 7, 20198/5/2019Safety, Tolerability and Pharmacodynamic Effect of Fazirsiran (TAK-999, ARO-AAT)A Placebo-Controlled, Multi-dose, Phase 2 Study to Determine the Safety, Tolerability and Pharmacodynamic Effect of Fazirsiran (TAK-999, ARO-AAT) in Patients With Alpha-1 Antitrypsin Deficiency (AATD) [SEQUOIA]Alpha 1-Antitrypsin DeficiencyDrug: Fazisiran Injection;Other: PlaceboArrowhead PharmaceuticalsNULLActive, not recruiting18 Years75 YearsAll40Phase 2United States;Germany;Italy;Netherlands;Portugal;Spain;Canada;Ireland;Sweden
12EUCTR2018-003385-14-IE
(EUCTR)
06/08/201921/03/2019A 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)A Placebo-Controlled, Multi-dose, Phase 2/3 Study to Determine the Safety, Tolerability and Effect on Liver Histologic Parameters in Response to ARO-AAT in Patients with Alpha-1 Antitrypsin Deficiency (AATD) [SEQUOIA] alpha-1 antitrypsin deficiency (AATD)-associated liver disease
MedDRA version: 23.0;Level: LLT;Classification code 10001806;Term: Alpha-1 anti-trypsin deficiency;System Organ Class: 10001806 - Alpha-1 anti-trypsin deficiency;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ARO-AAT Injection
Product Code: ARO-AAT
INN or Proposed INN: ADS-001
Arrowhead Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2;Phase 3United States;Portugal;Canada;Spain;Poland;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden
13EUCTR2019-000068-86-GB
(EUCTR)
01/07/201903/04/2019A 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)A Pilot Open Label, Multi-dose, Phase 2 Study to Assess the Safety and Efficacy of ARO-AAT in Patients with Alpha-1 Antitrypsin Deficiency Associated Liver Disease (AATD) alpha-1 antitrypsin deficiency (AATD)-associated liver disease
MedDRA version: 23.1;Level: LLT;Classification code 10001806;Term: Alpha-1 anti-trypsin deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ARO-AAT Injection
Product Code: ARO-AAT
INN or Proposed INN: ADS-001
Arrowhead Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
16Phase 2Austria;Germany;United Kingdom
14NCT03362242
(ClinicalTrials.gov)
March 12, 201830/11/2017Study of ARO-AAT in Normal Adult VolunteersA Phase 1 Single and Multiple Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Effect of ARO-AAT on Serum Alpha-1 Antitrypsin Levels in Normal Adult VolunteersAlpha 1-Antitrypsin DeficiencyDrug: ARO-AAT Injection;Other: Sterile Normal Saline (0.9% NaCl)Arrowhead PharmaceuticalsNULLCompleted18 Years55 YearsAll45Phase 1New Zealand
15EUCTR2019-000068-86-DE
(EUCTR)
04/06/2019A 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)A Pilot Open Label, Multi-dose, Phase 2 Study to Assess the Safety and Efficacy of ARO-AAT in Patients with Alpha-1 Antitrypsin Deficiency Associated Liver Disease (AATD) alpha-1 antitrypsin deficiency (AATD)-associated liver disease
MedDRA version: 23.1;Level: LLT;Classification code 10001806;Term: Alpha-1 anti-trypsin deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ARO-AAT Injection
Product Code: ARO-AAT
INN or Proposed INN: ADS-001
Arrowhead Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
16Phase 2Austria;Germany;United Kingdom