231. Alpha-1-antitrypsin deficiency Clinical trials / Disease details


Clinical trials : 89 Drugs : 89 - (DrugBank : 16) / Drug target genes : 35 - Drug target pathways : 47

  
7 trials found
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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
2NCT03679598
(ClinicalTrials.gov)
April 8, 201918/9/2018Alvelestat (MPH966) for the Treatment of ALpha-1 ANTitrypsin DeficiencyA First in Class Disease Modifying Therapy to Treat Alpha-1 Antitrypsin Deficiency a Genetically Linked Orphan DiseaseAlpha-1 Antitrypsin Deficiency (AATD);Pi*ZZ, Pi*SZ, Pi*Null, Another Rare Phenotype/Genotype Known to be Associated With Either Low or Functionally Impaired AAT Including F or I Mutations;Emphysema or COPDDrug: Alvelestat (MPH966);Other: PlaceboUniversity of Alabama at BirminghamNational Institutes of Health (NIH);Mereo BioPharmaRecruiting18 Years80 YearsAll66Phase 2United States
3EUCTR2018-001309-95-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
4EUCTR2018-001309-95-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
5EUCTR2018-001309-95-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: 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;Belgium;Spain;Poland;Denmark;United Kingdom;Sweden
6NCT03636347
(ClinicalTrials.gov)
October 29, 201820/6/2018A 12-week Study Treating Participants Who Have alpha1-antitrypsin-related COPD With Alvelestat (MPH966) or Placebo.A 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;Emphysema;COPDDrug: Placebo Oral Tablet;Drug: Alvelestat oral tablet - dose 1;Drug: Alvelestat oral tablet - dose 2Mereo BioPharmaSyneos HealthActive, not recruiting18 Years75 YearsAll165Phase 2United States;Belgium;Canada;Denmark;Poland;Spain;Sweden;United Kingdom
7EUCTR2018-001309-95-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: 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