Alpha1-proteinase Inhibitor ( DrugBank: Alpha1-proteinase Inhibitor )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
231α1−アンチトリプシン欠乏症15
299嚢胞性線維症2

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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2015-004110-23-PL
(EUCTR)
19/04/201816/02/2018A Study with an active treatment to Assess the Long-term Safety of Weekly Intravenous Product in Subjects with Pulmonary Emphysema due to Alpha1-Antitrypsin DeficiencyAn 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 LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Estonia;Canada;Poland;Denmark;Australia;Russian Federation;New Zealand;Sweden
2NCT02796937
(ClinicalTrials.gov)
July 20163/6/2016Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin DeficiencyAn 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 DeficiencyPulmonary Emphysema in Alpha-1 Antitrypsin DeficiencyBiological: Alpha-1 MPGrifols Therapeutics LLCNULLEnrolling by invitation20 Years72 YearsAll250Phase 3United States;Australia;Canada;Denmark;Estonia;New Zealand;Poland;Russian Federation;Sweden
3EUCTR2015-004110-23-DK
(EUCTR)
29/03/201629/01/2016A Study with an active treatment to Assess the Long-term Safety of Weekly Intravenous Product in Subjects with Pulmonary Emphysema due to Alpha1-Antitrypsin DeficiencyAn 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 LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Estonia;Spain;Russian Federation;France;Canada;Argentina;Brazil;Poland;Romania;Denmark;Australia;Germany;New Zealand;Sweden
4EUCTR2013-001870-38-DE
(EUCTR)
21/09/201527/03/2015A 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 DeficiencyA 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.NULLNot RecruitingFemale: yes
Male: yes
339Phase 3United States;Estonia;Finland;Spain;Ireland;Russian Federation;France;Canada;Argentina;Poland;Brazil;Romania;Australia;Denmark;Germany;New Zealand;Sweden
5EUCTR2013-001870-38-PL
(EUCTR)
30/10/201429/08/2014A 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 DeficiencyA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
339United States;Estonia;Slovakia;Finland;Spain;Ireland;France;Canada;Argentina;Poland;Brazil;Romania;Australia;Denmark;New Zealand;Sweden
6EUCTR2013-001870-38-IE
(EUCTR)
21/03/201427/09/2013A 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 DeficiencyA 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.NULLNot RecruitingFemale: yes
Male: yes
339Phase 3Serbia;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
7EUCTR2013-001870-38-FI
(EUCTR)
30/01/201430/12/2013A 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 DeficiencyA 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 LLCNULLAuthorised-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): noSerbia;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
8EUCTR2013-001870-38-SE
(EUCTR)
09/01/201423/09/2013A 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 DeficiencyA 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 LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
339Phase 3United States;Serbia;Estonia;Finland;Spain;Ireland;Russian Federation;United Kingdom;France;Canada;Brazil;Poland;Romania;Australia;Denmark;Germany;Moldova, Republic of;New Zealand;Sweden
9EUCTR2013-001870-38-ES
(EUCTR)
26/12/201318/10/2013A 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 DeficiencyA 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.NULLNot 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): noUnited 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
10EUCTR2013-001870-38-DK
(EUCTR)
20/11/201304/10/2013A 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 DeficiencyA 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 LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
339Phase 3Serbia;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
11EUCTR2013-001870-38-EE
(EUCTR)
12/11/201301/10/2013A 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 DeficiencyA 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 LLCNULLAuthorised-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): noSerbia;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
12NCT01213043
(ClinicalTrials.gov)
November 201029/9/2010Safety and Pharmacokinetics of Alpha-1 Proteinase Inhibitor in Subjects With Alpha1-Antitrypsin DeficiencyA 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 DeficiencyEmphysema;Alpha 1-antitrypsin Deficiency (AATD)Biological: Prolastin-C, 60 mg/kg;Biological: Prolastin-C, 120 mg/kgGrifols Therapeutics Inc.NULLCompleted18 Years70 YearsAll30Phase 2United States
13NCT00396006
(ClinicalTrials.gov)
October 20063/11/2006Efficacy and Safety Study of Augmentation Therapy With ARALAST Fraction IV-1 (Human Alpha 1 - Proteinase Inhibitor)The Effect of Augmentation Therapy With ARALAST Fraction IV-1 (ARALAST) Alpha1-Proteinase Inhibitor (a1-PI) on the Level of a1-PI and Other Analytes in the Bronchoalveolar (BAL) Epithelial Lining Fluid (ELF)Alpha 1-Antitrypsin DeficiencyBiological: Alpha1-Proteinase InhibitorBaxalta now part of ShireNULLCompleted18 YearsN/AAll21Phase 4Australia;New Zealand
14NCT00242385
(ClinicalTrials.gov)
December 200519/10/2005Pharmacokinetic Study of ARALAST (Human Alpha1- PI)Single-Dose, Double-Blind, Crossover Study to Evaluate the Pharmacokinetic Comparability of ARALAST Fraction IV-1 Alpha1-Proteinase Inhibitor (ARALAST Fr. IV-1) and ARALASTAlpha 1-Antitrypsin DeficiencyBiological: Dose of 60 mg/kg Fraction IV-1 Alpha1-Proteinase Inhibitor;Biological: Dose of 60 mg/kg alpha1-proteinase inhibitorBaxalta now part of ShireBaxter Healthcare, Ltd. (New Zealand), Baxter Healthcare Pty. Ltd. (Australia)Completed18 YearsN/AAll25Phase 1Australia;New Zealand
15NCT00263887
(ClinicalTrials.gov)
December 200312/9/2005Alpha-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 DeficiencyDrug: Alpha1-Proteinase Inhibitor (Human);Drug: Albumin (Human) 20%, United States Pharmacopeia (USP)Grifols Therapeutics Inc.NULLCompleted18 YearsN/AAll77Phase 2Denmark;Sweden;United Kingdom

299. 嚢胞性線維症


臨床試験数 : 1,695 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01684410
(ClinicalTrials.gov)
August 20126/9/2012Safety and Tolerability Trial of Inhaled Alpha1-Proteinase Inhibitor (Human), Hydrophobic Chromatography Process (Alpha-1 HC) in Subjects With Cystic FibrosisA Three Week Dose Escalation, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Tolerability of 100 mg or 200 mg of Inhaled Alpha-1 HC, Once a Day in Subjects With Cystic Fibrosis.Cystic FibrosisBiological: Alpha-1 HC 100 mg;Biological: Placebo;Biological: Alpha-1 HC 200 mgGrifols Therapeutics Inc.NULLCompleted18 YearsN/AAll30Phase 2United States
2NCT00486837
(ClinicalTrials.gov)
December 200313/6/2007Deposition of Inhaled Prolastin in Cystic Fibrosis PatientsMulticenter, Randomized, Parallel Group Study to Investigate the Optimal Deposition Site for Inhaled Prolastin® in Patients With Cystic Fibrosis (CF)Cystic FibrosisDrug: Alpha1-Proteinase Inhibitor (Human)Grifols Therapeutics Inc.NULLCompleted8 YearsN/AAll72Phase 2NULL