172. 低ホスファターゼ症 Hypophosphatasia Clinical trials / Disease details

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

2 trials found

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	NCT01406977 (ClinicalTrials.gov)	July 2011	29/7/2011	Dose Escalation Study to Evaluate the Safety and Tolerability of Multiple Infusions of BPS804 in Adults With Hypophosphatasia (HPP)	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 (HPP).	Hypophosphatasia	Drug: BPS804	Novartis Pharmaceuticals	NULL	Completed	18 Years	70 Years	Both	9	Phase 2	Germany
2	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	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	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]	Product Name: BPS804 Product Code: BPS804 Other descriptive name: fully human IgG2 lambda monoclonal antibody	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	9		Germany