78. 下垂体前葉機能低下症 Hypopituitarism Clinical trials / Disease details


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

  
5 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-000929-42-NL
(EUCTR)
14/04/202223/02/2021Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiencyforesiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt Adult Growth Hormone Deficiency (AGHD)
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: lonapegsomatropin drug product
Product Code: ACP-011
INN or Proposed INN: LONAPEGSOMATROPIN
Other descriptive name: TRANSCON PEG40 HGH
Product Name: lonapegsomatropin drug product
Product Code: ACP-011
INN or Proposed INN: LONAPEGSOMATROPIN
Other descriptive name: TRANSCON PEG40 HGH
Trade Name: Norditropin FlexPro 5 mg/1.5 mL
Product Name: Norditropin FlexPro 5 mg/1.5 ml
INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli)
Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone)
Trade Name: Humatrope® 6 mg, powder and solvent for solution for injection
Product Code: H01AC01
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone)
Ascendis Pharma Endocrinology Division A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Turkey;Israel;United Kingdom;Italy;France;Armenia;Canada;Poland;Romania;Denmark;Australia;Georgia;Bulgaria;Netherlands;Germany;Japan;New Zealand
2EUCTR2020-000929-42-DK
(EUCTR)
05/08/202112/01/2021Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiencyforesiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt Adult Growth Hormone Deficiency (AGHD)
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: lonapegsomatropin drug product
Product Code: ACP-011
INN or Proposed INN: LONAPEGSOMATROPIN
Other descriptive name: TRANSCON PEG40 HGH
Product Name: lonapegsomatropin drug product
Product Code: ACP-011
INN or Proposed INN: LONAPEGSOMATROPIN
Other descriptive name: TRANSCON PEG40 HGH
Trade Name: Norditropin FlexPro 5 mg/1.5 mL
INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli)
Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone)
Trade Name: Humatrope® 6 mg, powder and solvent for solution for injection
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone)
Ascendis Pharma Endocrinology Division A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Bulgaria;Georgia;Germany;New Zealand;Japan
3EUCTR2020-000929-42-DE
(EUCTR)
09/06/202114/10/2020Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiencyforesiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt Adult Growth Hormone Deficiency (AGHD)
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: lonapegsomatropin drug product
Product Code: ACP-011
INN or Proposed INN: LONAPEGSOMATROPIN
Other descriptive name: TRANSCON PEG40 HGH
Product Name: lonapegsomatropin drug product
Product Code: ACP-011
INN or Proposed INN: LONAPEGSOMATROPIN
Other descriptive name: TRANSCON PEG40 HGH
Trade Name: Norditropin FlexPro 5 mg/1.5 mL
INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli)
Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone)
Trade Name: Humatrope® 6 mg, powder and solvent for solution for injection
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone)
Ascendis Pharma Endocrinology Division A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Bulgaria;Georgia;Germany;New Zealand;Japan
4EUCTR2020-000929-42-SK
(EUCTR)
12/04/202124/11/2020Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiencyforesiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt Adult Growth Hormone Deficiency (AGHD)
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: lonapegsomatropin drug product
Product Code: ACP-011
INN or Proposed INN: LONAPEGSOMATROPIN
Other descriptive name: TRANSCON PEG40 HGH
Product Name: lonapegsomatropin drug product
Product Code: ACP-011
INN or Proposed INN: LONAPEGSOMATROPIN
Other descriptive name: TRANSCON PEG40 HGH
Trade Name: Norditropin FlexPro 5 mg/1.5 mL
INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli)
Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone)
Trade Name: Humatrope® 6 mg, powder and solvent for solution for injection
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone)
Ascendis Pharma Endocrinology Division A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan
5EUCTR2020-000929-42-GR
(EUCTR)
23/03/202104/03/2021foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt Adult Growth Hormone Deficiency (AGHD)
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: lonapegsomatropin drug product
Product Code: ACP-011
INN or Proposed INN: LONAPEGSOMATROPIN
Other descriptive name: TRANSCON PEG40 HGH
Product Name: lonapegsomatropin drug product
Product Code: ACP-011
INN or Proposed INN: LONAPEGSOMATROPIN
Other descriptive name: TRANSCON PEG40 HGH
Trade Name: Norditropin FlexPro 5 mg/1.5 mL
INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli)
Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone)
Trade Name: Humatrope® 6 mg, powder and solvent for solution for injection
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone)
Ascendis Pharma Endocrinology Division A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3Belarus;Serbia;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Denmark;Australia;Netherlands;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Bulgaria;Georgia;Germany;Japan;New Zealand