Ach-0145228 (DrugBank: -)
1 disease| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 62 | 発作性夜間ヘモグロビン尿症 | 2 |
| 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 | EUCTR2019-003830-17-GB (EUCTR) | 16/09/2020 | 16/06/2020 | Study of the Oral Factor D (fD) Inhibitor ACH-0145228 in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients as Monotherapy and with background use of an Approved C5 Inhibitor | A Phase 2 Open-Label Proof of Concept Study to Assess the Efficacy, Safety, and Pharmacokinetics of the Oral Factor D (FD) Inhibitor ACH-0145228 in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients as Monotherapy and with an Approved C5 Inhibitor as Background Therapy | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALXN2050 Product Code: ACH-0145228 INN or Proposed INN: N/A Other descriptive name: ACH-0145228 Product Name: ALXN2050 Product Code: ACH-0145228 INN or Proposed INN: N/A Other descriptive name: ACH-0145228 | Achillion Pharmaceuticals, Inc., a wholly owned subsidiary of Alexion Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 26 | Phase 2 | United States;New Zealand;Italy;United Kingdom;Korea, Republic of | ||
| 2 | NCT04170023 (ClinicalTrials.gov) | December 16, 2019 | 6/11/2019 | Proof of Concept Study of ACH-0145228 in Paroxysmal Nocturnal Hemoglobinuria (PNH) | A Phase 2 Open-Label Proof of Concept Study to Assess the Efficacy, Safety, and Pharmacokinetics of the Oral Factor D (FD) Inhibitor ACH-0145228 in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients as Monotherapy and With an Approved C5 Inhibitor as Background Therapy | Paroxysmal Nocturnal Hemoglobinuria (PNH) | Drug: ALXN2050;Drug: C5 inhibitor background therapy | Alexion Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 26 | Phase 2 | United States;Italy;Korea, Republic of;New Zealand;United Kingdom |