VX-864 ( 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5

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
1NCT05643495
(ClinicalTrials.gov)
February 23, 202329/11/2022A Study to Evaluate Efficacy and Safety of VX-864 in Participants With the PiZZ GenotypeA Phase 2, Open-label Study Evaluating Efficacy and Safety of VX-864 in Subjects With Alpha-1 Antitrypsin Deficiency Who Have the PiZZ Genotype, Over 48 WeeksAlpha-1 Antitrypsin DeficiencyDrug: VX-864Vertex Pharmaceuticals IncorporatedNULLRecruiting18 Years80 YearsAll20Phase 2United States
2EUCTR2019-004881-16-IE
(EUCTR)
29/10/202009/07/2020Evaluation of the Efficacy and Safety of VX-864 in Subjects With the PiZZ GenotypeA Phase 2, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of VX-864 in PiZZ Subjects Alpha 1 antitrypsin deficiency in Subjects With the PiZZ Genotype
MedDRA version: 23.1;Level: PT;Classification code 10083869;Term: Alpha-1 antitrypsin deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: VX864
Product Code: VX864
INN or Proposed INN: VX864
Other descriptive name: VX-864
Product Name: VX864
Product Code: VX864
INN or Proposed INN: VX864
Other descriptive name: VX-864
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
40Phase 2United States;Canada;Ireland;Germany;United Kingdom;Sweden
3EUCTR2019-004881-16-DE
(EUCTR)
17/09/202010/07/2020Evaluation of the Efficacy and Safety of VX-864 in Subjects With the PiZZ GenotypeA Phase 2, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of VX-864 in PiZZ Subjects Alpha 1 antitrypsin deficiency in Subjects With the PiZZ Genotype
MedDRA version: 23.1;Level: PT;Classification code 10083869;Term: Alpha-1 antitrypsin deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: VX864
Product Code: VX864
INN or Proposed INN: VX864
Other descriptive name: VX-864
Product Name: VX864
Product Code: VX864
INN or Proposed INN: VX864
Other descriptive name: VX-864
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
40Phase 2United States;Canada;Ireland;Germany;United Kingdom;Sweden
4EUCTR2019-004881-16-GB
(EUCTR)
14/09/202021/07/2020Evaluation of the Efficacy and Safety of VX-864 in Subjects With the PiZZ GenotypeA Phase 2, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of VX-864 in PiZZ Subjects - VX19-864-101 Efficacy and Safety of VX-864 Alpha 1 antitrypsin deficiency in Subjects With the PiZZ Genotype
MedDRA version: 23.0;Level: PT;Classification code 10083869;Term: Alpha-1 antitrypsin deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: VX864
Product Code: VX864
Other descriptive name: VX-864
Product Name: VX864
Product Code: VX864
Other descriptive name: VX-864
Product Name: VX864
Product Code: VX864
Other descriptive name: VX-864
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2United States;Canada;Ireland;Netherlands;Germany;United Kingdom;Sweden
5EUCTR2019-004881-16-SE
(EUCTR)
11/09/202014/07/2020Evaluation of the Efficacy and Safety of VX-864 in Subjects With the PiZZ GenotypeA Phase 2, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of VX-864 in PiZZ Subjects Alpha 1 antitrypsin deficiency in Subjects With the PiZZ Genotype
MedDRA version: 23.1;Level: PT;Classification code 10083869;Term: Alpha-1 antitrypsin deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: VX864
Product Code: VX864
INN or Proposed INN: VX-864
Other descriptive name: VX-864
Product Name: VX864
Product Code: VX864
INN or Proposed INN: VX-864
Other descriptive name: VX-864
Product Name: VX864
Product Code: VX864
INN or Proposed INN: VX-864
Other descriptive name: VX-864
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
40Phase 2United States;Canada;Ireland;Germany;United Kingdom;Sweden