231. α1-アンチトリプシン欠乏症
［臨床試験数：83，薬物数：89（DrugBank：16），標的遺伝子数：35，標的パスウェイ数：46］
Searched query = "Alpha-1-antitrypsin deficiency", "AATD"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| 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 | EUCTR2015-004110-23-PL (EUCTR) | 19/04/2018 | 16/02/2018 | A Study with an active treatment to Assess the Long-term Safety of Weekly Intravenous Product 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-Proteinase Inhibitor (Human), ModifiedProcess 60 mg/kg in Subjects With Pulmonary Emphysema Due to Alpha1-Antitrypsin Deficiency - SPARTA-OLE | Pulmonary Emphysema due to Alpha-1-Antitrypsin Deficiency MedDRA version: 20.0;Level: LLT;Classification code 10014563;Term: Emphysema pulmonary;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Prolastin-C INN or Proposed INN: Alpha1-Proteinase Inhibitor (Human) Other descriptive name: ALPHA-1-ANTITRYPSIN | Grifols Therapeutics LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Estonia;Canada;Poland;Denmark;Australia;Russian Federation;New Zealand;Sweden | ||
| 2 | EUCTR2013-001870-38-DE (EUCTR) | 21/09/2015 | 27/03/2015 | A Controlled Study with an active treatment and a Placebo to Assess the Efficacy and Safety of Weekly Intravenous Product in Subjects with Pulmonary Emphysema due to Alpha-1 Antitrypsin Deficiency | A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Two Dose Regimens (60 mg/kg and 120 mg/kg) of Weekly Intravenous Alphal-Proteinase Inhibitor (Human) in Subjects with Pulmonary Emphysema due to Alphal-Antitrypsin Deficiency - SPARTA | Pulmonary Emphysema due to Alpha-1-Antitrypsin Deficiency MedDRA version: 19.0;Level: LLT;Classification code 10014563;Term: Emphysema pulmonary;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Prolastin-C Product Name: Alpha1-Proteinase Inhibitor (Human) Product Code: Prolastin-C INN or Proposed INN: Alpha1-Proteinase Inhibitor (Human) Other descriptive name: ALPHA-1-ANTITRYPSIN | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 339 | Phase 3 | United States;Estonia;Finland;Spain;Ireland;Russian Federation;France;Canada;Argentina;Poland;Brazil;Romania;Australia;Denmark;Germany;New Zealand;Sweden | ||
| 3 | EUCTR2013-001870-38-PL (EUCTR) | 30/10/2014 | 29/08/2014 | A Controlled Study with an active treatment and a Placebo to Assess the Efficacy and Safety of Weekly Intravenous Product in Subjects with Pulmonary Emphysema due to Alpha-1 Antitrypsin Deficiency | A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Two Dose Regimens (60 mg/kg and 120 mg/kg) of Weekly Intravenous Alphal-Proteinase Inhibitor (Human) in Subjects with Pulmonary Emphysema due to Alphal-Antitrypsin Deficiency - SPARTA | Pulmonary Emphysema due to Alpha-1-Antitrypsin Deficiency MedDRA version: 17.1;Level: LLT;Classification code 10014563;Term: Emphysema pulmonary;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Prolastin-C Product Name: Alpha1-Proteinase Inhibitor (Human) Product Code: Prolastin-C INN or Proposed INN: Alpha1-Proteinase Inhibitor (Human) Other descriptive name: ALPHA-1-ANTITRYPSIN | Grifols Therapeutics Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 339 | United States;Estonia;Slovakia;Finland;Spain;Ireland;France;Canada;Argentina;Poland;Brazil;Romania;Australia;Denmark;New Zealand;Sweden | |||
| 4 | EUCTR2013-001870-38-IE (EUCTR) | 21/03/2014 | 27/09/2013 | A Controlled Study with an active treatment and a Placebo to Assess the Efficacy and Safety of Weekly Intravenous Product in Subjects with Pulmonary Emphysema due to Alpha-1 Antitrypsin Deficiency | A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Two Dose Regimens (60 mg/kg and 120 mg/kg) of Weekly Intravenous Alphal-Proteinase Inhibitor (Human) in Subjects with Pulmonary Emphysema due to Alphal-Antitrypsin Deficiency - SPARTA | Pulmonary Emphysema due to Alpha-1-Antitrypsin Deficiency MedDRA version: 16.0;Level: LLT;Classification code 10014563;Term: Emphysema pulmonary;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Prolastin-C Product Name: Alpha1-Proteinase Inhibitor (Human) Product Code: Prolastin-C INN or Proposed INN: Alpha1-Proteinase Inhibitor (Human) Other descriptive name: ALPHA-1-ANTITRYPSIN | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 339 | Phase 3 | Serbia;United States;Estonia;Slovakia;Finland;Spain;Ireland;Lithuania;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Brazil;Denmark;Australia;Germany;Netherlands;Latvia;Norway;New Zealand;Sweden | ||
| 5 | EUCTR2013-001870-38-SE (EUCTR) | 09/01/2014 | 23/09/2013 | A Controlled Study with an active treatment and a Placebo to Assess the Efficacy and Safety of Weekly Intravenous Product in Subjects with Pulmonary Emphysema due to Alpha-1 Antitrypsin Deficiency | A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Two Dose Regimens (60 mg/kg and 120 mg/kg) of Weekly Intravenous Alphal-Proteinase Inhibitor (Human) in Subjects with Pulmonary Emphysema due to Alphal-Antitrypsin Deficiency - SPARTA | Pulmonary Emphysema due to Alpha-1-Antitrypsin Deficiency MedDRA version: 20.0;Level: LLT;Classification code 10014563;Term: Emphysema pulmonary;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Prolastin-C Product Name: Alpha1-Proteinase Inhibitor (Human) Product Code: Prolastin-C INN or Proposed INN: Alpha1-Proteinase Inhibitor (Human) Other descriptive name: ALPHA-1-ANTITRYPSIN | Grifols Therapeutics LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 339 | Phase 3 | United States;Serbia;Estonia;Finland;Spain;Ireland;Russian Federation;United Kingdom;France;Canada;Brazil;Poland;Romania;Australia;Denmark;Germany;Moldova, Republic of;New Zealand;Sweden | ||
| 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 |
| 6 | NCT01213043 (ClinicalTrials.gov) | November 2010 | 29/9/2010 | Safety and Pharmacokinetics of Alpha-1 Proteinase Inhibitor in Subjects With Alpha1-Antitrypsin Deficiency | A Randomized Double-blind Crossover Study to Assess the Safety and Pharmacokinetics of Two Different Doses of Weekly Intravenous Administration of Alpha1-Proteinase Inhibitor (Human) Prolastin®-C in Subjects With Alpha1-Antitrypsin Deficiency | Emphysema;Alpha 1-antitrypsin Deficiency (AATD) | Biological: Prolastin-C, 60 mg/kg;Biological: Prolastin-C, 120 mg/kg | Grifols Therapeutics Inc. | NULL | Completed | 18 Years | 70 Years | All | 30 | Phase 2 | United States |