H01AC01 ( 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2

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
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agemin
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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
2EUCTR2009-016783-37-SE
(EUCTR)
07/01/201016/10/2009The Effects of 18-Month Replacement with a Very Low Fixed Dose vs. Standard Dose of Growth Hormone (GH) on Insulin Sensitivity, Body Composition, Bone Mass, Lipids, Muscle Strength and Quality of Life in GHD adults - VLAD-GHThe Effects of 18-Month Replacement with a Very Low Fixed Dose vs. Standard Dose of Growth Hormone (GH) on Insulin Sensitivity, Body Composition, Bone Mass, Lipids, Muscle Strength and Quality of Life in GHD adults - VLAD-GH Growth hormone deficiency in adultsProduct Name: Genotropin, Genotropin MiniQuick
Product Code: H01AC01
INN or Proposed INN: recombinant human growth hormone
Sahlgrenska University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Sweden