ADS-001 ( 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11

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
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
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
5EUCTR2019-000068-86-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
6EUCTR2018-003385-14-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
7EUCTR2018-003385-14-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
8EUCTR2018-003385-14-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
9EUCTR2018-003385-14-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
10EUCTR2019-000068-86-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
11EUCTR2019-000068-86-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