Pivotal study of A4250 in children with progressive familial intrahepatic cholestasis
Phase of Trial: Phase III
Latest Information Update: 18 May 2017
At a glance
- Drugs A 4250 (Primary)
- Indications Intrahepatic cholestasis
- Focus Therapeutic Use
- 18 May 2017 According to an Albireo Pharma media release, company has finalised key design for this study following consultations with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).
- 18 May 2017 According to an Albireo Pharma media release, this trial will have different primary endpoints for US and E.U. Primary endpoint for FDA evaluation, will be change in pruritus and for EMA evaluation will be sBA responder rate.
- 14 Mar 2017 According to an Albireo Pharma Inc. media release, the company met with the U.S. Food and Drug Administration (FDA) in the first quarter of 2017 and plans to meet with the European Medicines Agency (EMA) in the second quarter of 2017