Trial Profile

Odevixibat Pregnancy and Lactation Surveillance Program: A Post-marketing, Long-term, Observational, Descriptive Study to Assess the Risk of Pregnancy and Maternal Complications and Adverse Effects on the Developing Fetus, Neonate, and Infant Among Individuals Exposed to Odevixibat During Pregnancy and/or Lactation

Status: Recruiting

Phase of Trial: Phase IV

Latest Information Update: 07 Oct 2024

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At a glance

Drugs Odevixibat (Primary)
Indications Alagille syndrome; Biliary atresia; Cholestasis; Intrahepatic cholestasis
Focus Adverse reactions
Sponsors Ipsen

02 Apr 2024 Planned primary completion date changed from 2 Sep 2032 to 2 Sep 2031.
20 Feb 2024 New trial record

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