Humatrope® 6 mg, powder and solvent for solution for injection ( DrugBank: - )
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 | 4 |
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. | 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 | EUCTR2020-000929-42-DK (EUCTR) | 05/08/2021 | 12/01/2021 | 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: 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/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Serbia;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 | ||
| 2 | EUCTR2020-000929-42-DE (EUCTR) | 09/06/2021 | 14/10/2020 | 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: 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/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Japan;New Zealand;Germany;Bulgaria;Georgia;Romania;Poland;Canada;Armenia;United Kingdom;Turkey;Netherlands;Denmark;Australia;France;Italy;Israel;Russian Federation;Ukraine;Spain;Greece;Slovakia;United States;Belarus;Serbia | ||
| 3 | EUCTR2020-000929-42-SK (EUCTR) | 12/04/2021 | 24/11/2020 | 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: 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/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Serbia;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 | ||
| 4 | EUCTR2020-000929-42-GR (EUCTR) | 23/03/2021 | 04/03/2021 | 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 | 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/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Belarus;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 |