Somatropin (INN) recombinant DNA orgin, Escherichia coli ( DrugBank: Somatropin, Escherichia coli )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
78下垂体前葉機能低下症1

78. 下垂体前葉機能低下症


臨床試験数 : 492 薬物数 : 341 - (DrugBank : 47) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 100
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2004-000356-17-DK
(EUCTR)
19/04/200529/11/2004PHASE IIIB, INTERNATIONAL, SINGLE GROUP, OPEN STUDY TO DEFINE AN OPTIMAL MONITORING OF IGF-I IN CHILDREN TREATED WITH NUTROPINAQUSING A NOVEL CAPILLARY BLOOD COLLECTION METHOD - OptimaPHASE IIIB, INTERNATIONAL, SINGLE GROUP, OPEN STUDY TO DEFINE AN OPTIMAL MONITORING OF IGF-I IN CHILDREN TREATED WITH NUTROPINAQUSING A NOVEL CAPILLARY BLOOD COLLECTION METHOD - Optima Children presenting growth failure associated with Growth Hormone Deficiency (GHD), Tuner Syndrome (TS) or Chronic Renal Insufficiency (CRI).NutropinAq™ is given as a daily subcutaneous injection dose:GDH: 0,025- 0,035 mg/kg/day,TS : up to 0,05 mg/kg/day, CRI : up to 0,05 mg/kg/day.No dose adaptation will be allowed during the study period unless tolerance or safety mandates a dose reduction.
MedDRA version: 7.0;Classification code 10056438
Trade Name: NutropinAq
Product Name: NutropinAq
INN or Proposed INN: Somatropin
Other descriptive name: Somatropin (INN) recombinant DNA orgin, Escherichia coli
Beaufour Ipsen PharmaNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Finland;Denmark;Italy