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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%
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%
Coagulopathy
3%
Otitis media
3%
Gamma-glutamyltransferase increased
3%
Vitamin A decreased
3%
Headache
3%
Anaemia macrocytic
3%
Blood triglycerides increased
3%
Tonsillitis
3%
Contusion
3%
Oropharyngeal pain
3%
Pharyngeal inflammation
3%
Pharyngitis
3%
Viral infection
3%
Urticaria
3%
Frequent bowel movements
3%
Hypersensitivity
3%
Lymphadenopathy
3%
Vitamin E decreased
3%
Vitamin D deficiency
3%
Abdominal pain upper
3%
Faeces soft
3%
Asthma
3%
Hypophagia
3%
Hepatic enzyme increased
3%
Rhinitis allergic
3%
Pain in extremity
3%
Skin lesion
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-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
Find a Location
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
257 Previous Clinical Trials
55,095 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial offer novel treatments not seen before?
"First studied in 2018, Odevixibat has undergone 3 clinical trials thus far. The most recent one is still ongoing and includes 31 cities & 21 countries."
Answered by AI
Is Odevixibat a new drug being trialed?
"Odevixibat is currently being trialed in 3 live Phase 3 trials. However, these aren't the only clinical studies being conducted for Odevixibat as there are 133 active locations worldwide."
Answered by AI
How many individuals are included in this clinical research project?
"Recruitment for this trial concluded on October 17th, 2022. The study was first posted September 3rd, 2021. There are currently 1450 other trials admitting patients with alagille syndrome and 3 studies for odevixibat accepting patients."
Answered by AI
How many different medical clinics is this study being run in today?
"Patients can be enrolled at this trial at UCSF in San Francisco, California, Johns Hopkins Hospital in Baltimore, Maryland, Boston Children's Hospital in Boston, Massachusetts and 5 other sites."
Answered by AI
Are we currently enrolling patients for this experiment?
"The clinical trial mentioned is not currently looking for patients, as stated on clinicaltrials.gov. This study was first posted on September 3rd, 2021 and updated October 17th, 2022. There are 1453 other studies that are accepting patients at this time."
Answered by AI
Did the FDA give Odevixibat their stamp of approval?
"Odevixibat's safety is estimated to be a 3. This Phase 3 rating comes from both the efficacy data as well as multiple rounds of supportive safety data."
Answered by AI
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