Human recombinant tissue non-specific alkaline phosphatase fusion protein    (DrugBank: Alkaline Phosphatase)

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11

172. 低ホスファターゼ症 [臨床試験数:32,薬物数:18(DrugBank:4),標的遺伝子数:3,標的パスウェイ数:6
Searched query = "Hypophosphatasia"
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.
11 / 32 trials found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
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Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2015-003131-35-DE
(EUCTR)
19/04/201603/12/2015A Phase 2a Randomized, Multi-center, Open-Label, Pharmacokinetic, and Dose Response Study of Asfotase Alfa in Adult Patients with Pediatric-Onset HypophosphatasiaA Phase 2a Randomized, Multi-center, Open-Label, Pharmacokinetic, and Dose Response Study of Asfotase Alfa in Adult Patients with Pediatric-Onset Hypophosphatasia Hypophosphatasia is a rare inborn error of bone metabolism caused by inactivating mutations in the gene encoding the Tissue-nonspecific alkaline phosphatase isoenzyme.With deficiency of Tissue-nonspecific alkaline phosphatase, there is a buildup of extracellular inorganic pyrophosphate, which inhibits mineralization of bone matrix.
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
Alexion Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
36Phase 2United States;Germany
2EUCTR2015-000809-39-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
3EUCTR2010-019850-42-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
4EUCTR2010-019850-42-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
5EUCTR2010-019850-42-DE
(EUCTR)
04/03/201115/10/2010An 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 is a rare inborn error of bone metabolism caused by inactivating mutations in the gene encoding the Tissue-nonspecific alkaline phosphatase isoenzyme. With deficiency of Tissue-nonspecific alkaline phosphatase, there is a buildup of extracellular inorganic pyrophosphate, which inhibits mineralization of bone matrix.
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
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
Alexion Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Taiwan;Saudi Arabia;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Canada;Australia;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2008-007406-11-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
7NCT00739505
(ClinicalTrials.gov)
August 200819/8/2008Safety Study of Human Recombinant Tissue Non-Specific Alkaline Phosphatase Fusion Protein Asfotase Alfa in Adults With Hypophosphatasia (HPP)A Multicenter, Open-Label, Dose Escalating Study of the Safety, Tolerability and Pharmacology of Human Recombinant Tissue Non-Specific Alkaline Phosphatase Fusion Protein Asfotase Alfa in Adults With Hypophosphatasia (HPP)Hypophosphatasia (HPP)Biological: Asfotase AlfaAlexion PharmaceuticalsNULLCompleted18 Years80 YearsAll6Phase 1United States;Canada
8EUCTR2010-019850-42-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
9EUCTR2015-001128-52-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
10EUCTR2017-001831-38-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2017-003153-42-Outside-EU/EEA
(EUCTR)
03/08/2017Long-Term Safety and Efficacy of Asfotase Alfa in Children with Hypophosphatasia (HPP)Extension Study of Protocol ENB-006-09 Evaluating the Long-Term Safety and Efficacy ofAsfotase Alfa (Human Recombinant Tissue-Nonspecific Alkaline Phosphatase Fusion Protein) in Children 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
12Phase 2United States;Canada