ENB-0040 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
172低ホスファターゼ症12

172. 低ホスファターゼ症


臨床試験数 : 34 薬物数 : 19 - (DrugBank : 4) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 6
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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agemax
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PhaseCountries
1EUCTR2015-000809-39-FR
(EUCTR)
04/02/201605/08/2015Access Program for Asfotase AlfaAn Open-label, Multicenter, Expanded Access Program for Asfotase Alfa (human recombinant tissue-nonspecific alkaline phosphatase fusion protein) Treatment for Patients with Infantile- or Juvenile-onset Hypophosphatasia (HPP) Hypophosphatasia
MedDRA version: 18.0;Level: PT;Classification code 10049933;Term: Hypophosphatasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Strensiq
Product Name: Asfotas Alfa
Product Code: ENB-0040
INN or Proposed INN: ASFOTASE ALFA
Other descriptive name: Human Recombinant Tissue Non-Specific Alkaline Phosphatase Fusion Protein
Alexion Pharma International SàrlNULLNot RecruitingFemale: yes
Male: yes
100Phase 4France;Belgium;Spain;Russian Federation;Netherlands
2EUCTR2010-019850-42-ES
(EUCTR)
28/06/201309/04/2013An Open-Label, Multicenter, Multinational Study of the Safety, Efficacy and Pharmacokinetics of Asfotase alfa (human recombinant tissue nonspecific alkaline phosphatase fusion protein) in Infants and Children ? 5 Years of Age with Hypophosphatasia (HPP)An Open-Label, Multicenter, Multinational Study of the Safety, Efficacy and Pharmacokinetics of Asfotase alfa (human recombinant tissue nonspecific alkaline phosphatase fusion protein) in Infants and Children ? 5 Years of Age with Hypophosphatasia (HPP) Hypophosphatasia
MedDRA version: 14.1;Level: PT;Classification code 10049933;Term: Hypophosphatasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: Asfotase alfa
Product Code: ENB-0040
INN or Proposed INN: Asfotase alfa
Other descriptive name: Human recombinant tissue non-specific alkaline phosphatase fusion protein
Product Name: Asfotase alfa
Product Code: ENB-0040
INN or Proposed INN: Asfotase alfa
Other descriptive name: Human recombinant tissue non-specific alkaline phosphatase fusion protein
Alexion Pharma International SàrlNULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Saudi Arabia;Taiwan;Spain;Turkey;United Kingdom;Italy;France;Canada;Argentina;Australia;Germany;Japan
3EUCTR2010-019850-42-IT
(EUCTR)
09/05/201301/03/2013An Open-Label, Multicenter, Multinational Study of the Safety, Efficacy and Pharmacokinetics of Asfotase alfa (human recombinant tissue nonspecific alkaline phosphatase fusion protein) in Infants and Children = 5 Years of Age with Hypophosphatasia (HPP)An Open-Label, Multicenter, Multinational Study of the Safety, Efficacy and Pharmacokinetics of Asfotase alfa (human recombinant tissue nonspecific alkaline phosphatase fusion protein) in Infants and Children = 5 Years of Age with Hypophosphatasia (HPP) Hypophosphatasia
MedDRA version: 15.1;Level: PT;Classification code 10049933;Term: Hypophosphatasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: Asfotase alfa
Product Code: ENB-0040
INN or Proposed INN: Asfotase alfa
Other descriptive name: Human recombinant tissue non-specific alkaline phosphatase fusion protein
Product Name: Asfotase alfa
Product Code: ENB-0040
INN or Proposed INN: Asfotase alfa
Other descriptive name: Human recombinant tissue non-specific alkaline phosphatase fusion protein
Alexion Pharma International SàrlNULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Saudi Arabia;Taiwan;Spain;Turkey;Italy;United Kingdom;France;Canada;Argentina;Australia;Germany;Japan
4NCT01163149
(ClinicalTrials.gov)
June 201024/6/2010Safety and Efficacy Study of Asfotase Alfa in Adolescents and Adults With Hypophosphatasia (HPP)A Randomized, Open-Label, Multicenter, Multinational, Dose-Ranging, Concurrent Control Study of the Safety, Efficacy, Pharmacokinetic of ENB-0040 (Human Recombinant Tissue Nonspecific Alkaline Phosphatase Fusion Protein) in Adolescents and Adults With Hypophosphatasia (HPP)HypophosphatasiaDrug: asfotase alfaAlexion PharmaceuticalsNULLCompleted13 Years65 YearsAll19Phase 2United States;Canada
5NCT00952484
(ClinicalTrials.gov)
September 20093/8/2009Safety and Efficacy of Asfotase Alfa in Juvenile Patients With Hypophosphatasia (HPP)A Randomized, Open-Label, Multicenter, Multinational, Dose-Ranging, Historical Control Study of the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of ENB-0040 (Human Recombinant Tissue Nonspecific Alkaline Phosphatase Fusion Protein) in Children With Hypophosphatasia (HPP)Hypophosphatasia (HPP)Biological: asfotase alfaAlexion PharmaceuticalsNULLCompleted5 Years12 YearsAll13Phase 2United States;Canada
6NCT00894075
(ClinicalTrials.gov)
July 20094/5/2009Safety and Efficacy Study of ENB-0040 in Juvenile Patients With Hypophosphatasia (HPP)Single-Center, Case-Control Study of Safety, Efficacy and Pharmacokinetics of ENB-0040 (Human Recombinant Tissue Nonspecific Alkaline Phosphatase Fusion Protein) for Treatment of Hypophosphatasia in ChildrenHypophosphatasiaBiological: ENB-0040Alexion Pharma International SarlNULLWithdrawn5 Years12 YearsBoth0Phase 2United States
7NCT01205152
(ClinicalTrials.gov)
April 200917/9/2010Extension Study of Protocol ENB-002-08 - Study of Asfotase Alfa in Infants and Young Children With Hypophosphatasia (HPP)Extension Study of ENB-0040 (Human Recombinant Tissue-Nonspecific Alkaline Phosphatase Fusion Protein) in Severely Affected Infants and Young Children With Hypophosphatasia (HPP)HypophosphatasiaBiological: asfotase alfaAlexion PharmaceuticalsNULLCompleted24 Weeks42 MonthsAll10Phase 2United States;United Arab Emirates;United Kingdom
8EUCTR2009-009369-32-GB
(EUCTR)
30/03/200914/04/2009Extension open-label use of ENB-0040 for infantile hypophosphatasiaExtension Study of ENB-0040 (Human Recombinant Tissue-Nonspecific Alkaline Phosphatase Fusion Protein) in Severely Affected Infants and Young Children with Hypophosphatasia (HPP) Infantile hypoposphatasia
MedDRA version: 19.1;Level: PT;Classification code 10049933;Term: Hypophosphatasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Strensiq
Product Name: Asfotase alfa
Product Code: Asfotase alfa
INN or Proposed INN: Asfotase alfa
Other descriptive name: Human recombinant tissue non-specific alkaline phosphatase fusion protein
Alexion Pharma GmbHNULLNot Recruiting Female: yes
Male: yes
10 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;United Arab Emirates;United Kingdom
9EUCTR2008-007406-11-GB
(EUCTR)
25/02/200915/01/2009A Multicenter, Open-Label Study of the Safety, Tolerability and Pharmacology of ENB-0040 (Enobia’s human recombinant tissue non-specific alkaline phosphatase fusion protein) in up to 6 Severely Affected Patients with Infantile Hypophosphatasia (HPP)A Multicenter, Open-Label Study of the Safety, Tolerability and Pharmacology of ENB-0040 (Enobia’s human recombinant tissue non-specific alkaline phosphatase fusion protein) in up to 6 Severely Affected Patients with Infantile Hypophosphatasia (HPP) Infantile Hypophosphatasia
MedDRA version: 14.1;Level: PT;Classification code 10049933;Term: Hypophosphatasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Product Code: ENB-0040
Other descriptive name: Human Recombinant Tissue Non-Specific Alkaline Phosphatase Fusion Protein
Enobia Canada Limited PartnershipNULLNot RecruitingFemale: yes
Male: yes
10United Kingdom
10EUCTR2015-001128-52-Outside-EU/EEA
(EUCTR)
28/05/2015Safety and efficacy of asfotase alfa in children with hypophosphatasiaA Randomized, Open-Label, Multicenter, Multinational, Dose-Ranging, Historical Control Study of the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of ENB-0040 (Human Recombinant Tissue-Nonspecific Alkaline Phosphatase Fusion Protein) in Children with Hypophosphatasia (HPP) Hypophosphatasia (HPP)
MedDRA version: 18.0;Level: PT;Classification code 10049933;Term: Hypophosphatasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: Asfotase Alfa
INN or Proposed INN: ASFOTASE ALFA
Other descriptive name: Human recombinant tissue non-specific alkaline phosphatase fusion protein
Alexion Pharma International SàrlNULLNAFemale: yes
Male: yes
13United States;Canada
11EUCTR2010-019850-42-FR
(EUCTR)
28/09/2015An Open-Label, Multicenter, Multinational Study of the Safety, Efficacy and Pharmacokinetics of Asfotase alfa (human recombinant tissue nonspecific alkaline phosphatase fusion protein) in Infants and Children = 5 Years of Age with Hypophosphatasia (HPP)An Open-Label, Multicenter, Multinational Study of the Safety, Efficacy and Pharmacokinetics of Asfotase alfa (human recombinant tissue nonspecific alkaline phosphatase fusion protein) in Infants and Children = 5 Years of Age with Hypophosphatasia (HPP) Hypophosphatasia
MedDRA version: 18.0;Level: PT;Classification code 10049933;Term: Hypophosphatasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: Asfotase alfa
Product Code: ENB-0040
INN or Proposed INN: Asfotase alfa
Other descriptive name: Human recombinant tissue non-specific alkaline phosphatase fusion protein
Product Name: Asfotase alfa
Product Code: ENB-0040
INN or Proposed INN: Asfotase alfa
Other descriptive name: Human recombinant tissue non-specific alkaline phosphatase fusion protein
Alexion Pharma International SàrlNULLNAFemale: yes
Male: yes
60Phase 2United States;Taiwan;Saudi Arabia;Spain;Turkey;United Kingdom;Italy;France;Canada;Argentina;Australia;Germany;Japan
12EUCTR2017-001831-38-Outside-EU/EEA
(EUCTR)
09/05/2017Safety and Efficacy Study of Asfotase Alfa in Adolescents and Adults With Hypophosphatasia (HPP)A Randomized, Open-Label, Multicenter, Multinational, Dose-Ranging, Concurrent Control Study of the Safety, Efficacy, and Pharmacokinetics of ENB-0040 (Human Recombinant Tissue-NonspecificAlkaline Phosphatase Fusion Protein) in Adolescents and Adults with Hypophosphatasia (HPP) Hypophosphatasia
MedDRA version: 20.0;Level: PT;Classification code 10049933;Term: Hypophosphatasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Strensiq
Product Name: Asfotase alfa
INN or Proposed INN: ASFOTASE ALFA
Other descriptive name: Human recombinant tissue non-specific alkaline phosphatase fusion protein
INN or Proposed INN: ASFOTASE ALFA
Other descriptive name: Human recombinant tissue non-specific alkaline phosphatase fusion protein
Alexion Pharma GmbHNULLNAFemale: yes
Male: yes
19Phase 2United States;Canada