Mecasermin ( DrugBank: Mecasermin )


5 diseases
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4
96クローン病1
168エーラス・ダンロス症候群1
265脂肪萎縮症1
299嚢胞性線維症1

78. 下垂体前葉機能低下症


臨床試験数 : 494 薬物数 : 385 - (DrugBank : 49) / 標的遺伝子数 : 44 - 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
1EUCTR2010-020742-10-GB
(EUCTR)
09/05/201104/11/2010Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy.Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy. Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Trade Name: INCRELEX 10 mg/ml
INN or Proposed INN: Mecasermin
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Ipsen PharmaNULLNot RecruitingFemale: yes
Male: yes
63Phase 2Finland;United Kingdom;Spain;Sweden
2EUCTR2010-020742-10-ES
(EUCTR)
01/04/201107/01/2011Tratamiento combinado con factor de crecimiento insulínico tipo I recombinante (rhIGFI) y hormona de crecimiento (rhGH) en niños prepuberales con déficit idiopático de hormona de crecimiento y mala respuesta al primer año de tratamiento con hormona de crecimiento. Ensayo Clínico de fase II, prospectivo, aleatorizado, abierto, multicéntrico de grupos paralelos en los que se compara dosis fija de rhGH mas dosis flexibles de rhIGFI versus dosis fija de rhGH - No aplicaTratamiento combinado con factor de crecimiento insulínico tipo I recombinante (rhIGFI) y hormona de crecimiento (rhGH) en niños prepuberales con déficit idiopático de hormona de crecimiento y mala respuesta al primer año de tratamiento con hormona de crecimiento. Ensayo Clínico de fase II, prospectivo, aleatorizado, abierto, multicéntrico de grupos paralelos en los que se compara dosis fija de rhGH mas dosis flexibles de rhIGFI versus dosis fija de rhGH - No aplica Niños pre-puberales con déficit idiopático de hormona de crecimiento
MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency
Trade Name: NUTROPINAq 10 mg/2 ml (30 UI), solución inyectable
INN or Proposed INN: SOMATROPINA
Other descriptive name: SOMATROPIN
Trade Name: INCRELEX 10 mg/ml, solución inyectable
INN or Proposed INN: AGUA PARA PREPARACIONES INYECTABLES
Other descriptive name: AGUA PARA PREPARACIONES INYECTABLES
INN or Proposed INN: MECASERMINA
Other descriptive name: MECASERMINA
Trade Name: INCRELEX 10 mg/ml, solución inyectable
INN or Proposed INN: AGUA PARA PREPARACIONES INYECTABLES
Other descriptive name: AGUA PARA PREPARACIONES INYECTABLES
INN or Proposed INN: MECASERMINA
Other descriptive name: MECASERMINA
Ipsen PharmaNULLNot RecruitingFemale: yes
Male: yes
63Finland;United Kingdom;Spain;Sweden
3EUCTR2010-020742-10-SE
(EUCTR)
23/02/201119/11/2010Comparison of efficacy and safety of Nutropin (rhGH) associated with Increlex (rhIGF-1) vs Nutropin (rhGH) alone [COGROW].Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy. Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and with poor response after one year of treatment.
MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Trade Name: INCRELEX 10 mg/ml
INN or Proposed INN: Mecasermin
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Ipsen PharmaNULLNot RecruitingFemale: yes
Male: yes
63Phase 2Finland;United Kingdom;Spain;Sweden
4EUCTR2010-020742-10-FI
(EUCTR)
10/01/201122/11/2010Comparison of efficacy and safety of Nutropin (rhGH) associated with Increlex (rhIGF-1) vs Nutropin (rhGH) alone [COGROW].Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy. Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and with poor response after one year of treatment.
MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Trade Name: INCRELEX 10 mg/ml
INN or Proposed INN: Mecasermin
Trade Name: NutropinAq 10 mg/2 ml
INN or Proposed INN: Somatropin
Ipsen PharmaNULLNot RecruitingFemale: yes
Male: yes
63Phase 2Finland;United Kingdom;Spain;Sweden

96. クローン病


臨床試験数 : 2,400 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 168 - 標的パスウェイ数 : 214
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2010-022215-19-GB
(EUCTR)
21/07/201123/06/2011Combined growth hormone and IGF1 therapy in paediatric Crohn'd diseaseA Pharmacokinetic Study Of The Combined Use Of Recombinant Human GH And IGF-1 In Children With Inflammatory Bowel (Crohn’s) Disease - Combination rhGH + rhIGF-1 in childhood/adolescent Crohn’s Impaired growth in Paediatric Crohn's disease
MedDRA version: 14.1;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Increlex
Product Name: Increlex 10mg/ml solution for injection
INN or Proposed INN: Mecasermin [rDNA Origin] 10mg/ml solution
Other descriptive name: Recombinant human Insulin-like Growth Factor
Trade Name: NutropinAq®
Product Name: NutropinAq 10mg/2ml solution for injection
INN or Proposed INN: Somatropin(rhGH)
Other descriptive name: recombinant growth hormone
Greater Glasgow & Clyde NHSNULLNot RecruitingFemale: yes
Male: yes
24Phase 2United Kingdom

168. エーラス・ダンロス症候群


臨床試験数 : 8 薬物数 : 17 - (DrugBank : 9) / 標的遺伝子数 : 9 - 標的パスウェイ数 : 55
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01446783
(ClinicalTrials.gov)
September 201127/9/2011IGF-I Stimulation of Collagen Synthesis in Ehlers-Danlos PatientsIGF-I Stimulation of Collagen Synthesis in Ehlers-Danlos PatientsEhlers-Danlos Syndrome, ClassicDrug: mecasermin;Drug: SalineBispebjerg HospitalNULLCompleted18 YearsN/ABoth15N/ADenmark

265. 脂肪萎縮症


臨床試験数 : 116 薬物数 : 170 - (DrugBank : 61) / 標的遺伝子数 : 26 - 標的パスウェイ数 : 97
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01329744
(ClinicalTrials.gov)
June 20114/4/2011Effects of IGF-I in HIV Metabolic DiseaseEffects of Recombinant IGF-I in HIV Associated Metabolic DiseaseHIV LipodystrophyDrug: mecasermin;Drug: Placebo controlUniversity of Texas Southwestern Medical CenterNULLTerminated18 Years60 YearsBoth16Phase 1United States

299. 嚢胞性線維症


臨床試験数 : 1,696 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-002719-27-IT
(EUCTR)
30/12/201113/03/2012EFFECT OF RECOMBINANT HUMAN INSULIN-LIKE GROWTH FACTOR-I ON GLUCOSE TOLERANCE AND AS PREVENTION TOWARDS THE DEVELOPMENT OF CYSTIC FIBROSIS RELATED DIABETES MELLITUSGLUCOSE METABOLISM AND INFLAMMATORY PARAMETERS UNDER IGF-I TREATMENT IN CYSTIC FIBROSIS - RH-IGF-I IN CYSTIC FIBROSIS PATIENTS WITH CYSTIC FIBROSIS
MedDRA version: 14.1;Level: PT;Classification code 10011766;Term: Cystic fibrosis pancreatic;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: INCRELEX*SC 1FL 4ML 10MG/ML
INN or Proposed INN: MECASERMIN
AZIENDA OSPEDALIERA DI PARMANULLNot RecruitingFemale: yes
Male: yes
20Italy