WHO ICTRP trial
ALXN1210 Versus Eculizumab in Adult Patients with Paroxysmal Nocturnal…
EUCTR2016-002026-36-GB · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2016-002026-36-GB |
|---|---|
| Public title | ALXN1210 Versus Eculizumab in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) currently Treated With Eculizumab |
| Scientific title | A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab |
| Primary sponsor | Alexion Pharmaceuticals Incorporated |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | United States;Spain;Netherlands;Germany;United Kingdom |
| Conditions | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1 Level: LLT Classification code 10055629 Term: Paroxysmal nocturnal hemoglobinuria System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases… |
| Interventions | Product Code: ALXN1210 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Current Sponsor code: ALXN1210 Other descriptive name: Fc- and CDR-modified… |
| Registration date | Feb 14, 2017 |
| Target size | 192 |
| Secondary IDs | ALXN1210-PNH-302 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: