Alvelestat tosylate ( DrugBank: Alvelestat )


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
1EUCTR2018-001309-95-BE
(EUCTR)
06/09/201902/07/2019A Phase 2 placebo-controlled study to evaluate the mechanistic effect, safety, and tolerability of alvelestat (MPH966) in participants with alpha-1 antitrypsin deficiencyA Phase 2, proof-of-concept, multicentre, double-blind, randomised, dose-ascending, sequential group, placebo-controlled study to evaluate the mechanistic effect, safety, and tolerability of 12 weeks twice daily oral administration of alvelestat (MPH966) in participants with alpha-1 antitrypsin deficiency. Alpha-1 antitrypsin deficiency
MedDRA version: 23.1;Level: LLT;Classification code 10001806;Term: Alpha-1 anti-trypsin deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Alvelestat
Product Code: MPH966
INN or Proposed INN: Alvelestat tosylate
Other descriptive name: ALVELESTAT
Mereo BioPharma 4 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
182Phase 2United States;Canada;Spain;Poland;Belgium;Denmark;United Kingdom;Sweden
2EUCTR2018-001309-95-PL
(EUCTR)
05/04/201910/12/2018A Phase 2 placebo-controlled study to evaluate the mechanistic effect, safety, and tolerability of alvelestat (MPH966) in participants with alpha-1 (PiZZ or null genotype/phenotype) antitrypsin deficiencyA Phase 2, proof-of-concept, multicentre, double-blind, randomised, dose-ascending, sequential group, placebo-controlled study to evaluate the mechanistic effect, safety, and tolerability of 12 weeks twice daily oral administration of alvelestat (MPH966) in participants with alpha-1 (PiZZ or null genotype/phenotype) antitrypsin deficiency. Alpha-1 antitrypsin deficiency
MedDRA version: 23.1;Level: LLT;Classification code 10001806;Term: Alpha-1 anti-trypsin deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Alvelestat
Product Code: MPH966
INN or Proposed INN: Alvelestat tosylate
Other descriptive name: ALVELESTAT
Mereo BioPharma 4 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
182Phase 2United States;Canada;Spain;Belgium;Poland;Denmark;United Kingdom;Sweden
3EUCTR2018-001309-95-GB
(EUCTR)
30/11/201831/07/2018A Phase 2 placebo-controlled study to evaluate the mechanistic effect, safety, and tolerability of alvelestat (MPH966) in participants with alpha-1 antitrypsin deficiencyA Phase 2, proof-of-concept, multicentre, double-blind, randomised, dose-ascending, sequential group, placebo-controlled study to evaluate the mechanistic effect, safety, and tolerability of 12 weeks twice daily oral administration of alvelestat (MPH966) in participants with alpha-1 antitrypsin deficiency. Alpha-1 antitrypsin deficiency
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] - Respiratory Tract Diseases [C08]
Product Name: Alvelestat
Product Code: MPH966
INN or Proposed INN: Alvelestat tosylate
Other descriptive name: ALVELESTAT
Mereo BioPharma 4 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
182Phase 2United States;Canada;Poland;Belgium;Spain;Denmark;United Kingdom;Sweden
4EUCTR2018-001309-95-DK
(EUCTR)
14/11/201813/09/2018A Phase 2 placebo-controlled study to evaluate the mechanistic effect, safety, and tolerability of alvelestat (MPH966) in participants with alpha-1 antitrypsin deficiencyA Phase 2, proof-of-concept, multicentre, double-blind, randomised, dose-ascending, sequential group, placebo-controlled study to evaluate the mechanistic effect, safety, and tolerability of 12 weeks twice daily oral administration of alvelestat (MPH966) in participants with alpha-1 antitrypsin deficiency. Alpha-1 antitrypsin deficiency
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] - Respiratory Tract Diseases [C08]
Product Name: Alvelestat
Product Code: MPH966
INN or Proposed INN: Alvelestat tosylate
Other descriptive name: ALVELESTAT
Mereo BioPharma 4 LtdNULLNot RecruitingFemale: yes
Male: yes
182Phase 2Canada;Sweden;Belgium;United States;Denmark;Poland;United Kingdom;Spain
5EUCTR2018-001309-95-SE
(EUCTR)
16/10/201806/09/2018A Phase 2 placebo-controlled study to evaluate the mechanistic effect, safety, and tolerability of alvelestat (MPH966) in participants with alpha-1 antitrypsin deficiencyA Phase 2, proof-of-concept, multicentre, double-blind, randomised, dose-ascending, sequential group, placebo-controlled study to evaluate the mechanistic effect, safety, and tolerability of 12 weeks twice daily oral administration of alvelestat (MPH966) in participants with alpha-1 antitrypsin deficiency. Alpha-1 antitrypsin deficiency
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] - Respiratory Tract Diseases [C08]
Product Name: Alvelestat
Product Code: MPH966
INN or Proposed INN: Alvelestat tosylate
Other descriptive name: ALVELESTAT
Mereo BioPharma 4 LtdNULLNot RecruitingFemale: yes
Male: yes
182Phase 2Canada;Sweden;Belgium;United States;Denmark;Poland;United Kingdom;Spain