Macimorelin acetate (DrugBank: Macimorelin, Acetate)
43 diseases告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
---|---|---|
1 | 球脊髄性筋萎縮症 | 0 |
2 | 筋萎縮性側索硬化症 | 0 |
6 | パーキンソン病 | 0 |
10 | シャルコー・マリー・トゥース病 | 0 |
13 | 多発性硬化症/視神経脊髄炎 | 0 |
35 | 天疱瘡 | 0 |
40 | 高安動脈炎 | 0 |
46 | 悪性関節リウマチ | 0 |
49 | 全身性エリテマトーデス | 0 |
51 | 全身性強皮症 | 0 |
60 | 再生不良性貧血 | 0 |
64 | 血栓性血小板減少性紫斑病 | 0 |
67 | 多発性嚢胞腎 | 0 |
70 | 広範脊柱管狭窄症 | 0 |
71 | 特発性大腿骨頭壊死症 | 0 |
73 | 下垂体性TSH分泌亢進症 | 0 |
75 | クッシング病 | 0 |
76 | 下垂体性ゴナドトロピン分泌亢進症 | 0 |
78 | 下垂体前葉機能低下症 | 4 |
79 | 家族性高コレステロール血症(ホモ接合体) | 0 |
81 | 先天性副腎皮質酵素欠損症 | 0 |
83 | アジソン病 | 0 |
85 | 特発性間質性肺炎 | 0 |
86 | 肺動脈性肺高血圧症 | 0 |
88 | 慢性血栓塞栓性肺高血圧症 | 0 |
90 | 網膜色素変性症 | 0 |
96 | クローン病 | 0 |
97 | 潰瘍性大腸炎 | 0 |
113 | 筋ジストロフィー | 0 |
145 | ウエスト症候群 | 0 |
156 | レット症候群 | 0 |
162 | 類天疱瘡(後天性表皮水疱症を含む。) | 0 |
171 | ウィルソン病 | 0 |
206 | 脆弱X症候群 | 0 |
222 | 一次性ネフローゼ症候群 | 0 |
224 | 紫斑病性腎炎 | 0 |
225 | 先天性腎性尿崩症 | 0 |
227 | オスラー病 | 0 |
235 | 副甲状腺機能低下症 | 0 |
265 | 脂肪萎縮症 | 0 |
288 | 自己免疫性後天性凝固因子欠乏症[自己免疫性出血病XIII (~2017.3)] | 0 |
298 | 遺伝性膵炎 | 0 |
299 | 嚢胞性線維症 | 0 |
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 | EUCTR2018-001988-23-PL (EUCTR) | 19/04/2019 | 23/01/2019 | A clinical study with macimorelin acetate comparing three doses in their safety and tolerability in children with suspected growth hormone deficiency (GHD) | Open label, group comparison, dose escalation trial to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of macimorelin acetate after single oral dosing of 0.25 mg/kg, 0.5 mg/kg, and 1 mg/kg in pediatric patients with suspected growth hormone deficiency (GHD) | Diagnosis of Growth Hormone Deficiency MedDRA version: 21.0;Level: LLT;Classification code 10073227;Term: Growth hormone stimulation test;System Organ Class: 100000004848;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Trade Name: Macrilen Product Name: macimorelin INN or Proposed INN: macimorelin Other descriptive name: MACIMORELIN ACETATE | Aeterna Zentaris GmbH | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Serbia;Belarus;Hungary;Poland;Ukraine;Russian Federation | ||
2 | EUCTR2018-001988-23-HU (EUCTR) | 07/11/2018 | 05/09/2018 | A clinical study with macimorelin acetate comparing three doses in their safety and tolerability in children with suspected growth hormone deficiency (GHD) | Open label, group comparison, dose escalation trial to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of macimorelin acetate after single oral dosing of 0.25 mg/kg, 0.5 mg/kg, and 1 mg/kg in pediatric patients with suspected growth hormone deficiency (GHD) | Diagnosis of Growth Hormone Deficiency MedDRA version: 20.0;Level: LLT;Classification code 10073227;Term: Growth hormone stimulation test;System Organ Class: 100000004848 ;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Aeterna Zentaris GmbH | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Serbia;Hungary;Poland;Ukraine;Russian Federation | |||
3 | EUCTR2015-002337-22-DE (EUCTR) | 19/01/2016 | 09/11/2015 | Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adults | Confirmatory validation of oral macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the diagnosis of Adult Growth Hormone Deficiency (AGHD) in comparison with the Insulin Tolerance Test (ITT) - Validation of macimorelin as a test for Adult Growth Hormone Deficiency | Diagnosis of Adult Growth Hormone Deficiency (AGHD);Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Product Name: Macimorelin Product Code: AEZS-130 INN or Proposed INN: Macimorelin acetate Other descriptive name: MACIMORELIN ACETATE Product Name: Insulin INN or Proposed INN: Insulin Other descriptive name: INSULIN | Aeterna Zentaris GmbH | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Serbia;France;United States;Poland;Spain;Austria;Germany;Italy;United Kingdom | ||
4 | EUCTR2015-002337-22-AT (EUCTR) | 10/12/2015 | 30/10/2015 | Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adults | Confirmatory validation of oral macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the diagnosis of Adult Growth Hormone Deficiency (AGHD) in comparison with the Insulin Tolerance Test (ITT) - Validation of macimorelin as a test for Adult Growth Hormone Deficiency | Diagnosis of Adult Growth Hormone Deficiency (AGHD);Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Product Name: Macimorelin Product Code: AEZS-130 INN or Proposed INN: Macimorelin acetate Other descriptive name: MACIMORELIN ACETATE Product Name: Insulin INN or Proposed INN: Insulin Other descriptive name: INSULIN | Aeterna Zentaris GmbH | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Serbia;France;United States;Poland;Spain;Austria;Germany;Italy;United Kingdom |