109. 非典型溶血性尿毒症症候群 Atypical hemolytic uremic syndrome Clinical trials / Disease details
臨床試験数 : 114 / 薬物数 : 36 - (DrugBank : 7) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 11
| 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 | EUCTR2020-005186-13-SI (EUCTR) | 05/11/2021 | 14/09/2021 | Efficacy and safety of iptacopan (LNP023) in adult patients with atypical hemolytic uremic syndrome naïve to complement inhibitor therapy | A multicenter, single-arm, open label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult aHUS patients who are naive to complement inhibitor therapy | atypical hemolytic uremic syndrome MedDRA version: 20.1;Level: LLT;Classification code 10079841;Term: Atypical hemolytic uremic syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 3 | United States;Czechia;Taiwan;Slovenia;Greece;Austria;Russian Federation;United Kingdom;India;Hungary;Brazil;China;Japan;Korea, Republic of | ||
| 2 | EUCTR2020-005186-13-AT (EUCTR) | 26/08/2021 | 27/05/2021 | Efficacy and safety of iptacopan (LNP023) in adult patients with atypical hemolytic uremic syndrome naïve to complement inhibitor therapy | A multicenter, single-arm, open label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult aHUS patients who are naive to complement inhibitor therapy | atypical hemolytic uremic syndrome MedDRA version: 20.1;Level: LLT;Classification code 10079841;Term: Atypical hemolytic uremic syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 3 | United States;Czechia;Taiwan;Slovenia;Greece;Austria;Russian Federation;United Kingdom;India;Hungary;Brazil;China;Japan;Korea, Republic of |