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Bile Acid Sequestrant

Odevixibat for Alagille Syndrome (ASSERT Trial)

Phase 3
Waitlist Available
Research Sponsored by Albireo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to average of week 20 and 24, where baseline was calculated by averaging the last two values preceding start of treatment, and average of week 20 and week 24 was defined as the average of week 20 and week 24 values.
Awards & highlights

ASSERT Trial Summary

This trial is testing a new drug for Alagille Syndrome, comparing it to a fake (placebo) drug to see if it is effective and safe.

Eligible Conditions
  • Alagille Syndrome

ASSERT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to average of week 20 and 24, where baseline was calculated by averaging the last two values preceding start of treatment, and average of week 20 and week 24 was defined as the average of week 20 and week 24 values.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to average of week 20 and 24, where baseline was calculated by averaging the last two values preceding start of treatment, and average of week 20 and week 24 was defined as the average of week 20 and week 24 values. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Scratching Score
Secondary outcome measures
Serum Bile Acid Levels

Side effects data

From 2022 Phase 3 trial • 52 Patients • NCT04674761
29%
Diarrhoea
23%
Pyrexia
14%
COVID-19
11%
Abdominal pain
9%
Respiratory tract infection
9%
Cough
9%
Upper respiratory tract infection
9%
Bronchitis
9%
Haematoma
6%
Weight decreased
6%
Asthenia
6%
Conjunctivitis
6%
Vomiting
6%
Gastroenteritis
6%
Nasopharyngitis
3%
Vitamin A decreased
3%
Hypophagia
3%
Headache
3%
Anaemia macrocytic
3%
Tonsillitis
3%
Contusion
3%
Pain in extremity
3%
Oropharyngeal pain
3%
Pharyngeal inflammation
3%
Pharyngitis
3%
Viral infection
3%
Blood triglycerides increased
3%
Urticaria
3%
Coagulopathy
3%
Otitis media
3%
Frequent bowel movements
3%
Hypersensitivity
3%
Rhinitis allergic
3%
Gamma-glutamyltransferase increased
3%
Skin lesion
3%
Lymphadenopathy
3%
Hepatic enzyme increased
3%
Vitamin E decreased
3%
Vitamin D deficiency
3%
Abdominal pain upper
3%
Faeces soft
3%
Asthma
3%
Faeces discoloured
3%
Constipation
3%
Haematemesis
3%
Pneumonia
3%
Rhinovirus infection
3%
Nausea
3%
Alanine aminotransferase increased
3%
Ligament sprain
3%
Platelet count decreased
3%
Rhinorrhoea
3%
Jaundice
3%
Aphthous ulcer
3%
International normalised ratio increased
3%
Cataract cortical
100%
80%
60%
40%
20%
0%
Study treatment Arm
Odevixibat (A4250)
Placebo

ASSERT Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Odevixibat (A4250)Experimental Treatment1 Intervention
Capsules for oral administration once daily for 24 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Capsules for oral administration (to match active) once daily for 24 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Odevixibat
2021
Completed Phase 3
~60

Find a Location

Who is running the clinical trial?

AlbireoLead Sponsor
16 Previous Clinical Trials
1,119 Total Patients Enrolled
3 Trials studying Alagille Syndrome
150 Patients Enrolled for Alagille Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome
2021. "Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04674761.
~13 spots leftby Apr 2025
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