231. Alpha-1-antitrypsin deficiency Clinical trials / Disease details
Clinical trials : 93 / Drugs : 77 - (DrugBank : 8) / Drug target genes : 10 - Drug target pathways : 36
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2018-001309-95-BE (EUCTR) | 06/09/2019 | 02/07/2019 | A Phase 2 placebo-controlled study to evaluate the mechanistic effect, safety, and tolerability of alvelestat (MPH966) in participants with alpha-1 antitrypsin deficiency | 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 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 182 | Phase 2 | United States;Canada;Spain;Poland;Belgium;Denmark;United Kingdom;Sweden | ||
| 2 | EUCTR2018-001309-95-PL (EUCTR) | 05/04/2019 | 10/12/2018 | A 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 deficiency | 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 (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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 182 | Phase 2 | United States;Canada;Spain;Belgium;Poland;Denmark;United Kingdom;Sweden | ||
| 3 | EUCTR2018-001309-95-GB (EUCTR) | 30/11/2018 | 31/07/2018 | A Phase 2 placebo-controlled study to evaluate the mechanistic effect, safety, and tolerability of alvelestat (MPH966) in participants with alpha-1 antitrypsin deficiency | 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 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 182 | Phase 2 | United States;Canada;Poland;Belgium;Spain;Denmark;United Kingdom;Sweden | ||
| 4 | EUCTR2018-001309-95-DK (EUCTR) | 14/11/2018 | 13/09/2018 | A Phase 2 placebo-controlled study to evaluate the mechanistic effect, safety, and tolerability of alvelestat (MPH966) in participants with alpha-1 antitrypsin deficiency | 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 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 182 | Phase 2 | Canada;Sweden;Belgium;United States;Denmark;Poland;United Kingdom;Spain | ||
| 5 | NCT03636347 (ClinicalTrials.gov) | October 29, 2018 | 20/6/2018 | A 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;COPD | Drug: Placebo Oral Tablet;Drug: Alvelestat oral tablet - dose 1;Drug: Alvelestat oral tablet - dose 2 | Mereo BioPharma | Syneos Health | Completed | 18 Years | 75 Years | All | 99 | Phase 2 | United States;Belgium;Canada;Denmark;Poland;Spain;Sweden;United Kingdom |
| 6 | EUCTR2018-001309-95-SE (EUCTR) | 16/10/2018 | 06/09/2018 | A Phase 2 placebo-controlled study to evaluate the mechanistic effect, safety, and tolerability of alvelestat (MPH966) in participants with alpha-1 antitrypsin deficiency | 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 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 182 | Phase 2 | Canada;Sweden;Belgium;United States;Denmark;Poland;United Kingdom;Spain |