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Ion Exchange Resin
Odevixibat for Alagille Syndrome (ASSERT-EXT 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 baseline to weeks, 4, 12, 24, 48, and 72
Awards & highlights
ASSERT-EXT Trial Summary
This trial is testing a drug for long-term safety and effectiveness in patients with Alagille syndrome.
Who is the study for?
This trial is for patients with Alagille Syndrome who completed a previous 24-week study. They must be able to use an eDiary and agree to reliable contraception if sexually active. It's not for those with severe liver issues, non-compliance in the prior study, or hypersensitivity to odevixibat.Check my eligibility
What is being tested?
The trial tests the long-term safety and effectiveness of Odevixibat in individuals with Alagille Syndrome. It's an open-label extension meaning everyone knows they're getting Odevixibat and there’s no placebo group.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones may include gastrointestinal symptoms like diarrhea or stomach pain, liver-related issues since it targets bile acid production, and potential allergic reactions.
ASSERT-EXT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to weeks, 4, 12, 24, 48, and 72
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to weeks, 4, 12, 24, 48, and 72
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in pruritus
Secondary outcome measures
Change in Global Symptom Relief
Change in Quality of Life
Change in Sleep Parameters
+2 moreSide effects data
From 2022 Phase 3 trial • 52 Patients • NCT0467476129%
Diarrhoea
23%
Pyrexia
14%
COVID-19
11%
Abdominal pain
9%
Cough
9%
Bronchitis
9%
Upper respiratory tract infection
9%
Respiratory tract infection
9%
Haematoma
6%
Conjunctivitis
6%
Nasopharyngitis
6%
Asthenia
6%
Vomiting
6%
Gastroenteritis
6%
Weight decreased
3%
Ligament sprain
3%
Faeces discoloured
3%
Hypersensitivity
3%
Abdominal pain upper
3%
Faeces soft
3%
Pneumonia
3%
Tonsillitis
3%
Lymphadenopathy
3%
Oropharyngeal pain
3%
Aphthous ulcer
3%
Coagulopathy
3%
Haematemesis
3%
Anaemia macrocytic
3%
Cataract cortical
3%
Frequent bowel movements
3%
Vitamin E decreased
3%
Vitamin D deficiency
3%
Pain in extremity
3%
Asthma
3%
Urticaria
3%
Viral infection
3%
Alanine aminotransferase increased
3%
Blood triglycerides increased
3%
Rhinovirus infection
3%
International normalised ratio increased
3%
Jaundice
3%
Constipation
3%
Nausea
3%
Hepatic enzyme increased
3%
Platelet count decreased
3%
Hypophagia
3%
Otitis media
3%
Pharyngitis
3%
Gamma-glutamyltransferase increased
3%
Contusion
3%
Vitamin A decreased
3%
Headache
3%
Pharyngeal inflammation
3%
Rhinitis allergic
3%
Rhinorrhoea
3%
Skin lesion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Odevixibat (A4250)
Placebo
ASSERT-EXT Trial Design
1Treatment groups
Experimental Treatment
Group I: Odevixibat (A4250)Experimental Treatment1 Intervention
Capsules for oral administration once daily for 72 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Odevixibat
2021
Completed Phase 3
~60
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Who is running the clinical trial?
AlbireoLead Sponsor
16 Previous Clinical Trials
1,121 Total Patients Enrolled
3 Trials studying Alagille Syndrome
152 Patients Enrolled for Alagille Syndrome
Ipsen Medical DirectorStudy DirectorIpsen
259 Previous Clinical Trials
55,658 Total Patients Enrolled
2 Trials studying Alagille Syndrome
100 Patients Enrolled for Alagille Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You did not follow the instructions for taking the study drug or participating in the procedures in a previous study.I agree to use effective birth control or abstain from sex during and 90 days after the study.I do not have severe liver problems or symptoms like fluid in the abdomen, bleeding veins in my esophagus, or confusion.I have signed the consent form and will re-consent if I turn 18 during the study.You are allergic to any parts of odevixibat.
Research Study Groups:
This trial has the following groups:- Group 1: Odevixibat (A4250)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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