231. α1−アンチトリプシン欠乏症 Alpha-1-antitrypsin deficiency Clinical trials / Disease details
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. | 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 | EUCTR2015-004110-23-DK (EUCTR) | 29/03/2016 | 29/01/2016 | 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 Alphal-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;Spain;Russian Federation;France;Canada;Argentina;Brazil;Poland;Romania;Denmark;Australia;Germany;New Zealand;Sweden | ||
| 3 | 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 | ||
| 4 | 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 | |||
| 5 | 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 | ||
| 6 | EUCTR2013-001870-38-FI (EUCTR) | 30/01/2014 | 30/12/2013 | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Finland;Spain;Ireland;Russian Federation;United Kingdom;France;Canada;Argentina;Poland;Brazil;Romania;Australia;Denmark;Germany;New Zealand;Moldova, Republic of;Sweden | ||
| 7 | 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 | ||
| 8 | EUCTR2013-001870-38-ES (EUCTR) | 26/12/2013 | 18/10/2013 | 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: 14.1;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 | Not Recruiting | Female: yes Male: yes | 339 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Estonia;Slovakia;Finland;Spain;Ireland;Lithuania;United Kingdom;France;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Australia;Denmark;Germany;Norway;Netherlands;Latvia;New Zealand;Sweden | ||
| 9 | EUCTR2013-001870-38-DK (EUCTR) | 20/11/2013 | 04/10/2013 | 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 | Serbia;United States;Estonia;Finland;Spain;Ireland;Russian Federation;United Kingdom;France;Canada;Argentina;Poland;Brazil;Romania;Denmark;Australia;Germany;Moldova, Republic of;New Zealand;Sweden | ||
| 10 | EUCTR2013-001870-38-EE (EUCTR) | 12/11/2013 | 01/10/2013 | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Finland;Spain;Ireland;Russian Federation;United Kingdom;France;Canada;Argentina;Poland;Brazil;Romania;Australia;Denmark;Germany;New Zealand;Moldova, Republic of;Sweden | ||
| 11 | 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 |
| 12 | EUCTR2007-004869-18-GB (EUCTR) | 03/07/2008 | 04/04/2008 | Evaluation of the relative severity of pulmonary neutrophilic inflammation and therapeutic modification with IV Prolastin by means of 18 FDG PET/CT scanning in subjects with alpha1-antitrypsin deficiency. - ECLIPSE AATD | Evaluation of the relative severity of pulmonary neutrophilic inflammation and therapeutic modification with IV Prolastin by means of 18 FDG PET/CT scanning in subjects with alpha1-antitrypsin deficiency. - ECLIPSE AATD | The medical condition is emphysema and will be investigated in subjects with alpha 1-antitrypsin deficiency. MedDRA version: 9.1;Level: LLT;Classification code 10001811;Term: Alpha-1 proteinase inhibitor deficiency MedDRA version: 9.1;Classification code 10014563;Term: Emphysema pulmonary MedDRA version: 9.1;Classification code 10010952;Term: COPD MedDRA version: 9.1;Classification code 10006458;Term: Bronchitis chronic | Trade Name: Prolastin Product Name: Prolastin INN or Proposed INN: alpha 1-proteinase inhibitor (human) Other descriptive name: ALPHA-1-ANTITRYPSIN | UHB NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 26 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): | United Kingdom | ||
| 13 | NCT00295061 (ClinicalTrials.gov) | May 2006 | 20/2/2006 | Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MP and Prolastin In Alpha1-antitrypsin Deficient Adults | Multi-center, Randomized, Double-blind, Crossover Trial to Evaluate the Pharmacokinetic Comparability of Alpha-1 MP to Prolastin in Subjects With Alpha1-antitrypsin Deficiency. | 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 |
| 14 | NCT00263887 (ClinicalTrials.gov) | December 2003 | 12/9/2005 | Alpha-1-Antitrypsin (AAT) To Treat Emphysema In AAT-Deficient Patients (EXACTLE) | Multi-center, Randomized Trial With I.V. Prolastin® to Evaluate Frequency of Exacerbations and Progression of Emphysema by Means of Multi-slice CT Scans in Patients With Congenital Alpha-1-antitrypsin Deficiency. | Alpha 1-Antitrypsin Deficiency | Drug: Alpha1-Proteinase Inhibitor (Human);Drug: Albumin (Human) 20%, United States Pharmacopeia (USP) | Grifols Therapeutics Inc. | NULL | Completed | 18 Years | N/A | All | 77 | Phase 2 | Denmark;Sweden;United Kingdom |