WHO ICTRP trial
An Investigation of the Safety and Efficacy of Odevixibat in Patients with…
EUCTR2020-004011-28-FR · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2020-004011-28-FR |
|---|---|
| Public title | An Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndrome |
| Scientific title | A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT) |
| Primary sponsor | Albireo AB |
| 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;France;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy |
| Conditions | Alagille Syndrome MedDRA version: 20.0 Level: PT Classification code 10053870 Term: Alagille syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and… |
| Interventions | Product Name: Odevixibat Product Code: A4250 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Odevixibat CAS Number: 501692-44-0 Current Sponsor code: A4250 Other descriptive name: A4250 Concentration unit: µg microgram(s)… |
| Registration date | Nov 25, 2020 |
| Target size | 63 |
| Secondary IDs | A4250-012 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: