Alpha-1 MP
( DrugBank: - / KEGG DRUG: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 231 | α1−アンチトリプシン欠乏症 | 9 |
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
Showing 1 to 9 of 9 trials
| 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) | 06/09/201920190906 | 02/07/201920190702 | 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 placebo-controlled study to evaluate the mechanistic effect, safety, and tolerability of a ... | 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. A Phase 2, proof-of-concept, multicentre, double-blind, randomised, dose-ascending, sequential group ... | 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] Alpha-1antitrypsin deficiency MedDRA version: 23.1;Level: LLT;Classification code 10001806;Term: Alp ... | Product Name: Alvelestat Product Code: MPH966 INN or Proposed INN: Alvelestat tosylate Other descriptive name: ALVELESTAT Product Name: Alvelestat Product Code: MPH966 INN or Proposed INN: Alvelestat tosylate Other descriptiv ... | 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) | 05/04/201920190405 | 10/12/201820181210 | 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 placebo-controlled study to evaluate the mechanistic effect, safety, and tolerability of a ... | 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. A Phase 2, proof-of-concept, multicentre, double-blind, randomised, dose-ascending, sequential group ... | 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] Alpha-1antitrypsin deficiency MedDRA version: 23.1;Level: LLT;Classification code 10001806;Term: Alp ... | Product Name: Alvelestat Product Code: MPH966 INN or Proposed INN: Alvelestat tosylate Other descriptive name: ALVELESTAT Product Name: Alvelestat Product Code: MPH966 INN or Proposed INN: Alvelestat tosylate Other descriptiv ... | 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) | 30/11/201820181130 | 31/07/201820180731 | 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 placebo-controlled study to evaluate the mechanistic effect, safety, and tolerability of a ... | 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. A Phase 2, proof-of-concept, multicentre, double-blind, randomised, dose-ascending, sequential group ... | 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] Alpha-1antitrypsin deficiency MedDRA version: 20.1;Level: PT;Classification code 10001806;Term: Alph ... | Product Name: Alvelestat Product Code: MPH966 INN or Proposed INN: Alvelestat tosylate Other descriptive name: ALVELESTAT Product Name: Alvelestat Product Code: MPH966 INN or Proposed INN: Alvelestat tosylate Other descriptiv ... | 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) | 14/11/201820181114 | 13/09/201820180913 | 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 placebo-controlled study to evaluate the mechanistic effect, safety, and tolerability of a ... | 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. A Phase 2, proof-of-concept, multicentre, double-blind, randomised, dose-ascending, sequential group ... | 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] Alpha-1antitrypsin deficiency MedDRA version: 20.1;Level: PT;Classification code 10001806;Term: Alph ... | Product Name: Alvelestat Product Code: MPH966 INN or Proposed INN: Alvelestat tosylate Other descriptive name: ALVELESTAT Product Name: Alvelestat Product Code: MPH966 INN or Proposed INN: Alvelestat tosylate Other descriptiv ... | 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, 201820181029 | 20/6/201820180620 | A 12-week Study Treating Participants Who Have alpha1-antitrypsin-related COPD With Alvelestat (MPH966) or Placebo. A 12-week Study Treating Participants Who Have alpha1-antitrypsin-related COPD With Alvelestat (MPH9 ... | 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. A Phase 2, Proof-of-concept, Multicentre, Double-blind, Randomised, Dose-ascending, Sequential Group ... | Alpha 1-Antitrypsin Deficiency;Emphysema;COPD | Drug: Placebo Oral Tablet;Drug: Alvelestat oral tablet - dose 1;Drug: Alvelestat oral tablet - dose 2 Drug: Placebo Oral Tablet;Drug: Alvelestat oral tablet - dose 1;Drug: Alvelestat oral tablet - dose ... | 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) | 16/10/201820181016 | 06/09/201820180906 | 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 placebo-controlled study to evaluate the mechanistic effect, safety, and tolerability of a ... | 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. A Phase 2, proof-of-concept, multicentre, double-blind, randomised, dose-ascending, sequential group ... | 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] Alpha-1antitrypsin deficiency MedDRA version: 20.1;Level: PT;Classification code 10001806;Term: Alph ... | Product Name: Alvelestat Product Code: MPH966 INN or Proposed INN: Alvelestat tosylate Other descriptive name: ALVELESTAT Product Name: Alvelestat Product Code: MPH966 INN or Proposed INN: Alvelestat tosylate Other descriptiv ... | Mereo BioPharma 4 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 182 | Phase 2 | Canada;Sweden;Belgium;United States;Denmark;Poland;United Kingdom;Spain | ||
| 7 | NCT02796937 (ClinicalTrials.gov) | July 201620160700 | 3/6/201620160603 | Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency | An Open-Label, Multicenter Study to Evaluate the Long-term Safety of Weekly Intravenous Alpha1-Proteinase Inhibitor (Human), Modified Process 60 mg/kg in Subjects With Pulmonary Emphysema Due to Alpha1-Antitrypsin Deficiency An Open-Label, Multicenter Study to Evaluate the Long-term Safety of Weekly Intravenous Alpha1-Prote ... | Pulmonary Emphysema in Alpha-1 Antitrypsin Deficiency | Biological: Alpha-1 MP | Grifols Therapeutics LLC | NULL | Enrolling by invitation | 20 Years | 72 Years | All | 250 | Phase 3 | United States;Australia;Canada;Denmark;Estonia;New Zealand;Poland;Russian Federation;Sweden |
| 8 | NCT00301366 (ClinicalTrials.gov) | June 200620060600 | 8/3/200620060308 | The Safety and Tolerability of Alpha-1 Modified Process (MP) In Subjects With Alpha-1-antitrypsin (AAT) Deficiency The Safety and Tolerability of Alpha-1Modified Process (MP) In Subjects With Alpha-1-antitrypsin (AA ... | Multi-center, Open-label Trial to Evaluate the Safety and Tolerability of Alpha-1 MP in Subjects With Alpha-1-antitrypsin (AAT) Deficiency Multi-center, Open-label Trial to Evaluate the Safety and Tolerability of Alpha-1 MPin Subjects With ... | Alpha 1-Antitrypsin Deficiency | Drug: alpha-1 proteinase inhibitor (human) | Grifols Therapeutics Inc. | NULL | Completed | 18 Years | N/A | All | 38 | Phase 3 | United States;United Kingdom;Netherlands;Poland |
| 9 | NCT00295061 (ClinicalTrials.gov) | May 200620060500 | 20/2/200620060220 | Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MP and Prolastin In Alpha1-antitrypsin Deficient Adults Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MPand Prolastin In Alpha1-antitrypsin ... | Multi-center, Randomized, Double-blind, Crossover Trial to Evaluate the Pharmacokinetic Comparability of Alpha-1 MP to Prolastin in Subjects With Alpha1-antitrypsin Deficiency. Multi-center, Randomized, Double-blind, Crossover Trial to Evaluate the Pharmacokinetic Comparabilit ... | Alpha 1-Antitrypsin Deficiency | Drug: Alpha-1 MP;Drug: alpha-1 proteinase inhibitor (human) | Grifols Therapeutics Inc. | NULL | Completed | 18 Years | N/A | All | 24 | Phase 3 | United States |