Alkaline Phosphatase ( DrugBank: Alkaline Phosphatase )
4 diseases
告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
---|---|---|
46 | 悪性関節リウマチ | 2 |
93 | 原発性胆汁性胆管炎 | 7 |
97 | 潰瘍性大腸炎 | 3 |
172 | 低ホスファターゼ症 | 24 |
46. 悪性関節リウマチ
臨床試験数 : 4,356 / 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
Showing 1 to 2 of 2 diseases
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 | NCT01416493 (ClinicalTrials.gov) | May 2011 | 11/8/2011 | Bovine Intestinal Alkaline Phosphatase (bIAP) Modulating Rheumatoid Arthritis | An OPEN LABEL Phase II Safety Study of Bovine Intestinal Alkaline Phosphatase (bIAP), an Inflammation Modulating Moiety, in RA Patients An OPEN LABEL Phase II Safety Study of Bovine Intestinal Alkaline Phosphatase(bIAP), an Inflammation ... | Acute Rheumatoid Arthritis | Drug: s.c. injections of bovine intestinal Alkaline Phosphatase | Alloksys Life Sciences B.V. | Aix Scientifics | Completed | 18 Years | N/A | Both | 6 | Phase 1/Phase 2 | United Kingdom |
2 | EUCTR2008-007346-63-GB (EUCTR) | 05/04/2011 | 11/10/2010 | Reumap: An Open Label phase II study of Bovine Intestinal Alkaline Phosphatase (bIAP), An Inflammation modulating moiety, in RA patients - REUMAP Reumap: An Open Label phase II study of Bovine Intestinal Alkaline Phosphatase(bIAP), An Inflammatio ... | Reumap: An Open Label phase II study of Bovine Intestinal Alkaline Phosphatase (bIAP), An Inflammation modulating moiety, in RA patients - REUMAP Reumap: An Open Label phase II study of Bovine Intestinal Alkaline Phosphatase(bIAP), An Inflammatio ... | Rheumatoid Arthritis | Product Name: bIAP Product Code: EC 3.1.3.1 INN or Proposed INN: bovine intesastinal alkaline phosphatase (bIAP) Other descriptive name: bIAP Product Name: bIAP Product Code: EC 3.1.3.1 INN or Proposed INN: bovine intesastinal alkaline phosphat ... | Alloksys Life Sciences B.V. | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | United Kingdom |
93. 原発性胆汁性胆管炎
臨床試験数 : 298 / 薬物数 : 252 - (DrugBank : 59) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 115
Showing 1 to 7 of 7 diseases
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 | ChiCTR2000032053 | 2020-05-01 | 2020-04-19 | Application value of ultrasonography combined with transient elastography for staging of hepatic fibrosis in patients with primary biliary cholangitis (PBC) Application value of ultrasonography combined with transient elastography for staging of hepatic fib ... | Application value of ultrasonography combined with transient elastography for staging of hepatic fibrosis in patients with primary biliary cholangitis (PBC) Application value of ultrasonography combined with transient elastography for staging of hepatic fib ... | primary biliary cholangitis | Gold Standard:Any two of the following items met: 1. increased biochemical indicators of cholestasis such as alkaline phosphatase; 2. positive serum AMA or AMA-M2; 3. hepatic histopathology.;Index test:high-frequency and low-frequency ultrasound?transient elastography (TE); Gold Standard:Any two of the following items met: 1. increased biochemical indicators of cholestasis ... | You'an Hospital, Capital Medical University | NULL | Pending | 18 | 70 | Both | Target condition:100;Difficult condition:270 | N/A | China |
2 | EUCTR2016-004599-23-IT (EUCTR) | 26/02/2018 | 07/01/2021 | A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis ... | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess theEfficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase - GSN00300 A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess theEfficacy and Safety of Or ... | Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Prima ... | Product Code: GKT137831 INN or Proposed INN: GKT137831 | GENKYOTEX SA | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 2 | United States;Greece;Canada;Spain;Belgium;Israel;Germany;United Kingdom;Italy | ||
3 | EUCTR2016-004599-23-GR (EUCTR) | 27/10/2017 | 06/07/2017 | A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis ... | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of O ... | Primary Biliary Cholangitis MedDRA version: 20.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000023866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Primary Biliary Cholangitis MedDRA version: 20.0;Level: LLT;Classification code 10036680;Term: Prima ... | Product Code: GKT137831 INN or Proposed INN: GKT137831 Other descriptive name: GKT137831 | Genkyotex SA | NULL | Not Recruiting | Female: yes Male: yes | 102 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - ( ... | United States;Canada;Greece;Belgium;Spain;Israel;Germany;Italy;United Kingdom | ||
4 | EUCTR2016-004599-23-DE (EUCTR) | 19/09/2017 | 10/07/2017 | A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis ... | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of O ... | Primary Biliary Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Primary Biliary Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Prima ... | Product Code: GKT137831 INN or Proposed INN: GKT137831 Other descriptive name: GKT137831 | Genkyotex SA | NULL | Not Recruiting | Female: yes Male: yes | 102 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - ( ... | United States;Greece;Canada;Belgium;Spain;Israel;Germany;Italy;United Kingdom | ||
5 | EUCTR2016-004599-23-BE (EUCTR) | 10/08/2017 | 10/04/2017 | A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis ... | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of O ... | Primary Biliary Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Primary Biliary Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Prima ... | Product Code: GKT137831 INN or Proposed INN: GKT137831 Other descriptive name: GKT137831 | Genkyotex SA | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 2 | United States;Greece;Canada;Spain;Belgium;Israel;Germany;Italy;United Kingdom | ||
6 | EUCTR2016-004599-23-ES (EUCTR) | 26/07/2017 | 04/07/2017 | A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis ... | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of O ... | Primary Biliary Cholangitis MedDRA version: 20.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000023866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Primary Biliary Cholangitis MedDRA version: 20.0;Level: LLT;Classification code 10036680;Term: Prima ... | Product Code: GKT137831 INN or Proposed INN: GKT137831 Other descriptive name: GKT137831 | Genkyotex SA | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 2 | United States;Greece;Canada;Belgium;Spain;Israel;Germany;Italy;United Kingdom | ||
7 | EUCTR2016-004599-23-GB (EUCTR) | 30/06/2017 | 17/05/2017 | A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis ... | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of O ... | Primary Biliary Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Primary Biliary Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Prima ... | Product Code: GKT137831 INN or Proposed INN: GKT137831 Other descriptive name: GKT137831 | Genkyotex SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - ( ... | United States;Greece;Canada;Belgium;Spain;Israel;Germany;Italy;United Kingdom |
97. 潰瘍性大腸炎
臨床試験数 : 2,630 / 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
Showing 1 to 3 of 3 diseases
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 | EUCTR2006-000197-69-CZ (EUCTR) | 30/05/2006 | 10/03/2006 | A pilot, open-label, multi-center clinical trial to investigate the safety and efficacy of Bovine-Calf Intestinal Alkaline Phosphatase in patients with moderate to severe ulcerative colitis A pilot, open-label, multi-center clinical trial to investigate the safety and efficacy of Bovine-Ca ... | A pilot, open-label, multi-center clinical trial to investigate the safety and efficacy of Bovine-Calf Intestinal Alkaline Phosphatase in patients with moderate to severe ulcerative colitis A pilot, open-label, multi-center clinical trial to investigate the safety and efficacy of Bovine-Ca ... | Inflammatory Bowel Disease | Product Name: Bovine-Calf Alkaline Phosphatase (BIAP) | AM-Pharma B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Czech Republic;Italy | |||
2 | NCT00727324 (ClinicalTrials.gov) | May 2006 | 30/7/2008 | Safety/Efficacy Study of Bovine Intestinal Alkaline Phosphatase in Patients With Moderate to Severe Ulcerative Colitis Safety/Efficacy Study of Bovine Intestinal Alkaline Phosphatasein Patients With Moderate to Severe U ... | A Pilot, Open-label, Multi-center Clinical Trial to Investigate the Safety and Efficacy of Bovine-Calf Intestinal Alkaline Phosphatase in Patients With Moderate to Severe Ulcerative Colitis. A Pilot, Open-label, Multi-center Clinical Trial to Investigate the Safety and Efficacy of Bovine-Ca ... | Ulcerative Colitis | Drug: bovine intestinal alkaline phosphatase (BIAP) | AM-Pharma | CRM Biometrics GmbH;Sintesi Research Srl;Vigilex BV | Completed | 18 Years | N/A | Both | 22 | Phase 2 | Czech Republic;Italy |
3 | EUCTR2006-000197-69-IT (EUCTR) | 16/03/2006 | 05/06/2006 | A pilot, open-label, multi-center clinical trial to investigate the safety and efficacy of Bovine-Calf Intestinal Alkaline Phosphatase in patients with moderate to severe ulcerative colitis - AP IBD 02-02 A pilot, open-label, multi-center clinical trial to investigate the safety and efficacy of Bovine-Ca ... | A pilot, open-label, multi-center clinical trial to investigate the safety and efficacy of Bovine-Calf Intestinal Alkaline Phosphatase in patients with moderate to severe ulcerative colitis - AP IBD 02-02 A pilot, open-label, multi-center clinical trial to investigate the safety and efficacy of Bovine-Ca ... | Inflammatory Blowel Disease MedDRA version: 6.1;Level: PT;Classification code 10009900 | Product Name: Bovine-Calf Alkaline Phosphatase BIAP Product Code: BIAP | AM PHARMA B.V. | NULL | Not Recruiting | Female: yes Male: yes | 24 | Italy |
172. 低ホスファターゼ症
臨床試験数 : 34 / 薬物数 : 17 - (DrugBank : 4) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 6
Showing 1 to 10 of 24 diseases
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 |
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1 | NCT02496689 (ClinicalTrials.gov) | May 17, 2016 | 8/7/2015 | Expanded Access Program for Asfotase Alfa Treatment for Patients With Infantile- or Juvenile-onset Hypophosphatasia (HPP) Expanded Access Program for Asfotase Alfa Treatment for Patients With Infantile- or Juvenile-onset H ... | An 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) An Open-label, Multicenter, Expanded Access Program for Asfotase Alfa (Human Recombinant Tissue-nons ... | Hypophosphatasia | Biological: asfotase alfa | Alexion Pharmaceuticals | NULL | Approved for marketing | N/A | N/A | All | United States;France | ||
2 | EUCTR2015-003131-35-DE (EUCTR) | 19/04/2016 | 03/12/2015 | A Phase 2a Randomized, Multi-center, Open-Label, Pharmacokinetic, and Dose Response Study of Asfotase Alfa in Adult Patients with Pediatric-Onset Hypophosphatasia A Phase 2a Randomized, Multi-center, Open-Label, Pharmacokinetic, and Dose Response Study of Asfotas ... | A Phase 2a Randomized, Multi-center, Open-Label, Pharmacokinetic, and Dose Response Study of Asfotase Alfa in Adult Patients with Pediatric-Onset Hypophosphatasia A Phase 2a Randomized, Multi-center, Open-Label, Pharmacokinetic, and Dose Response Study of Asfotas ... | 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] Hypophosphatasia is a rare inborn error of bone metabolism caused by inactivating mutations in the g ... | 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 n ... | Alexion Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | United States;Germany | ||
3 | EUCTR2015-000809-39-FR (EUCTR) | 04/02/2016 | 05/08/2015 | Access Program for Asfotase Alfa | An 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) An Open-label, Multicenter, Expanded Access Program for Asfotase Alfa (human recombinant tissue-nons ... | 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] Hypophosphatasia MedDRA version: 18.0;Level: PT;Classification code 10049933;Term: Hypophosphatasia; ... | 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 Trade Name: Strensiq Product Name: Asfotas Alfa Product Code: ENB-0040 INN or Proposed INN: ASFOTASE AL ... | Alexion Pharma International Sàrl | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | France;Belgium;Spain;Russian Federation;Netherlands | ||
4 | NCT02531867 (ClinicalTrials.gov) | June 2015 | 11/8/2015 | Post-approval Clinical Study of Asfotase Alfa Treatment for Patients With Hypophosphatasia (HPP) in Japan Post-approval Clinical Study of Asfotase Alfa Treatment for Patients With Hypophosphatasia (HPP) in ... | A Multicenter, Post-Approval Clinical Study for Asfotase Alfa (Human Recombinant Tissue-nonspecific Alkaline Phosphatase Fusion Protein) Treatment for Patients With Hypophosphatasia (HPP) in Japan A Multicenter, Post-Approval Clinical Study for Asfotase Alfa (Human Recombinant Tissue-nonspecific ... | Hypophosphatasia | Biological: Asfotase Alfa | Alexion Pharmaceuticals | NULL | Completed | N/A | N/A | All | 13 | Phase 4 | NULL |
5 | JPRN-UMIN000014816 | 2014/08/11 | 11/08/2014 | A Multicenter study of the safety and efficacy of Asfotase Alfa (ALXN1215) (Human Recombinant Tissue Nonspecific Alkaline Phosphatase Fusion Protein) in patients with hypophosphatasia (HPP) A Multicenter study of the safety and efficacy of Asfotase Alfa (ALXN1215) (Human Recombinant Tissue ... | A Multicenter study of the safety and efficacy of Asfotase Alfa (ALXN1215) (Human Recombinant Tissue Nonspecific Alkaline Phosphatase Fusion Protein) in patients with hypophosphatasia (HPP) - Safety and efficacy of Asfotase Alfa in patients with hypophosphatasia (HPP) A Multicenter study of the safety and efficacy of Asfotase Alfa (ALXN1215) (Human Recombinant Tissue ... | hypophosphatasia | Drug: Asfotase Alfa (ALXN1215) Dose: 6mg/kg/week (divided 3 times a week) | HPP study group | Translational Research Informatics Center | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 20 | Not selected | Japan |
6 | NCT02456038 (ClinicalTrials.gov) | August 2014 | 26/3/2015 | Safety and Efficacy of Asfotase Alfa in Patients With Hypophosphatasia (HPP) | A Multicenter Study of the Safety and Efficacy of Asfotase Alfa (ALXN1215) (Human Recombinant Tissue Nonspecific Alkaline Phosphatase Fusion Protein) in Patients With Hypophosphatasia (HPP) A Multicenter Study of the Safety and Efficacy of Asfotase Alfa (ALXN1215) (Human Recombinant Tissue ... | Hypophosphatasia | Drug: Asfotase Alfa (ALXN1215) | Translational Research Informatics Center, Kobe, Hyogo, Japan | Osaka University Graduate School of Medicine | Completed | N/A | N/A | Both | 13 | Phase 2 | Japan |
7 | EUCTR2010-019850-42-GB (EUCTR) | 05/09/2013 | 01/02/2013 | 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) An Open-Label, Multicenter, Multinational Study of the Safety, Efficacy and Pharmacokinetics of Asfo ... | 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) An Open-Label, Multicenter, Multinational Study of the Safety, Efficacy and Pharmacokinetics of Asfo ... | Hypophosphatasia MedDRA version: 19.1;Level: PT;Classification code 10049933;Term: Hypophosphatasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] Hypophosphatasia MedDRA version: 19.1;Level: PT;Classification code 10049933;Term: Hypophosphatasia; ... | 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 Trade Name: Strensiq Product Name: Asfotase alfa INN or Proposed INN: Asfotase alfa Other descriptive n ... | Alexion Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - ( ... | United States;Taiwan;Saudi Arabia;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Canada;Australia;Germany;Japan United States;Taiwan;Saudi Arabia;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Canada ... | ||
8 | EUCTR2010-019850-42-ES (EUCTR) | 28/06/2013 | 09/04/2013 | 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) An Open-Label, Multicenter, Multinational Study of the Safety, Efficacy and Pharmacokinetics of Asfo ... | 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) An Open-Label, Multicenter, Multinational Study of the Safety, Efficacy and Pharmacokinetics of Asfo ... | 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] Hypophosphatasia MedDRA version: 14.1;Level: PT;Classification code 10049933;Term: Hypophosphatasia; ... | 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 Product Name: Asfotase alfa Product Code: ENB-0040 INN or Proposed INN: Asfotase alfa Other descriptive ... | Alexion Pharma International Sàrl | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Saudi Arabia;Taiwan;Spain;Turkey;United Kingdom;Italy;France;Canada;Argentina;Australia;Germany;Japan United States;Saudi Arabia;Taiwan;Spain;Turkey;United Kingdom;Italy;France;Canada;Argentina;Australi ... | ||
9 | EUCTR2010-019850-42-IT (EUCTR) | 09/05/2013 | 01/03/2013 | 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) An Open-Label, Multicenter, Multinational Study of the Safety, Efficacy and Pharmacokinetics of Asfo ... | 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) An Open-Label, Multicenter, Multinational Study of the Safety, Efficacy and Pharmacokinetics of Asfo ... | 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] Hypophosphatasia MedDRA version: 15.1;Level: PT;Classification code 10049933;Term: Hypophosphatasia; ... | 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 Product Name: Asfotase alfa Product Code: ENB-0040 INN or Proposed INN: Asfotase alfa Other descriptive ... | Alexion Pharma International Sàrl | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Saudi Arabia;Taiwan;Spain;Turkey;Italy;United Kingdom;France;Canada;Argentina;Australia;Germany;Japan United States;Saudi Arabia;Taiwan;Spain;Turkey;Italy;United Kingdom;France;Canada;Argentina;Australi ... | ||
10 | EUCTR2010-024013-31-DE (EUCTR) | 30/06/2011 | 07/02/2011 | A clinical study to evaluate the safety and preliminary efficacy of BPS804 in adults with hypophosphatasia A clinical study to evaluate the safety and preliminary efficacy of BPS804 in adults with hypophosph ... | An open-label, intra-patient dose-escalation study to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of multiple infusions of BPS804 in adults with hypophosphatasia An open-label, intra-patient dose-escalation study to evaluate the safety and tolerability, pharmaco ... | Hypophosphatasia (HPP) is a rare genetic metabolic disorder which results in impaired skeletal mineralization, and which is caused by the absence of or by deficient enzymatic activity of the tissue-nonspecific alkaline phosphatase (TNSALP) MedDRA version: 14.1;Level: PT;Classification code 10049933;Term: Hypophosphatasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] Hypophosphatasia (HPP) is a rare genetic metabolic disorder which results in impaired skeletal miner ... | Product Name: BPS804 Product Code: BPS804 Other descriptive name: fully human IgG2 lambda monoclonal antibody Product Name: BPS804 Product Code: BPS804 Other descriptive name: fully human IgG2 lambda monoclonal a ... | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 9 | Germany |