About this trial
This study will collect information from patients with ALGS who are using odevixibat in their daily lives. Odevixibat is a medication that helps patients with ALGS, a rare disease that affects the liver and causes itching.
The main aim of this study is to observe the long-term, everyday safety of the drug odevixibat in patients with ALGS who are receiving ongoing treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with ALGS.
On (or starting) active odevixibat treatment.
Aged 6 months or older at the time of consent.
Disqualifiers
Currently participating in a clinical trial with odevixibat.
Currently participating in any interventional clinical trial for ALGS.
Have any contraindication to odevixibat as per the locally approved label.
Trial population
Participants with Alagille syndrome (ALGS) who have been prescribed odevixibat by their treating physician will be enrolled into the study. Participants who started odevixibat treatment before study implementation may also be enrolled.
Trial design
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Percentage of participants experiencing adverse events (AEs)
An adverse event (AE) is any untoward medical occurrence in a participant administered odevixibat, whether or not considered related to treatment.
Percentage of participants experiencing serious adverse events (SAEs)
An adverse event (AE) is any untoward medical occurrence in a participant administered odevixibat, whether or not considered related to treatment.
Secondary outcomes
Percentage of participants with severe diarrhoea events
Percentage of participants with bloody diarrhoea events
Percentage of participants experiencing diarrhoea events with concurrent dehydration
Percentage of participants experiencing diarrhoea events treated with oral or intravenous rehydration