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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female patient with a clinical diagnosis of BA
Age at Kasai HPE ≤90 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to weeks 13, 26, 52 and 104
Awards & highlights
Study Summary
This trial will compare the effectiveness and safety of a new drug, odevixibat, to placebo in children with biliary atresia who have had a Kasai hepatoportoenterostomy.
Who is the study for?
This trial is for children with Biliary Atresia who've had a Kasai procedure before they were 90 days old. They should be able to start treatment within 3 weeks post-surgery and weigh more than 3.5kg. Children with severe liver issues, relying solely on IV nutrition, or having certain other conditions are not eligible.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of Odevixibat versus a placebo in kids after Kasai surgery for Biliary Atresia. It's a Phase 3 trial where participants are randomly assigned to either the drug or placebo without knowing which one they receive.See study design
What are the potential side effects?
While specific side effects aren't listed here, Odevixibat could potentially cause digestive issues, reactions at the site of administration, changes in liver enzymes, and possibly affect growth due to its role in bile acid processing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with biliary atresia.
Select...
I had the Kasai procedure done before I was 3 months old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to weeks 13, 26, 52 and 104
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to weeks 13, 26, 52 and 104
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time from randomization to first occurrence of liver transplant, or death
Secondary outcome measures
Percentage of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Percentage of participants with clinically significant changes in Abdominal Ultrasound findings
Percentage of participants with clinically significant changes in Laboratory Parameters (blood chemistry, hematology and coagulation)
+6 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%
Blood triglycerides increased
3%
Gamma-glutamyltransferase increased
3%
Hypophagia
3%
Vitamin A decreased
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%
Urticaria
3%
Frequent bowel movements
3%
Hypersensitivity
3%
Rhinitis allergic
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
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Odevixibat (A4250)Experimental Treatment1 Intervention
Capsules for oral administration once daily for 104 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Capsules for oral administration (to match active) once daily for 104 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
926 Total Patients Enrolled
1 Trials studying Biliary Atresia
180 Patients Enrolled for Biliary Atresia
Ipsen Medical DirectorStudy DirectorIpsen
257 Previous Clinical Trials
54,900 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with biliary atresia.I do not have any major health issues that could affect my safety or participation in the study.I have severe, untreatable fluid buildup in my abdomen.I have had surgery to remove part of my ileum.I have had a condition involving cysts in my bile ducts.I rely on IV nutrition or cannot take pills by mouth.I can start the study treatment within 3 weeks after my Kasai procedure.My blood clotting time is longer than normal but can be treated.I had the Kasai procedure done before I was 3 months old.I had a bile duct infection but it's resolved now.My weight is less than 3.5kg at the time of joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: Odevixibat (A4250)
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Are there any similar drugs to Odevixibat that have been trialed before?
"Odevixibat is being trialed in 3 active Phase 3 trials at the moment. Even though a few of the trials are based in Barcelona and Maryland, Odevixibat is being tested at a total of 133 different locations."
Answered by AI
Are people with the necessary medical conditions currently being accepted into the trial?
"Yes, this is an ongoing trial that was posted on July 10th, 2020 and updated most recently on May 16th, 2022 according to the information available on clinicaltrials.gov."
Answered by AI
Is this an innovative approach to research?
"There are 3 ongoing clinical trials for Odevixibat in 31 cities and 21 countries. The first trial was completed in 2018 and involved 120 patients. The trial reached Phase 3 during the drug approval stage. A total of 18,243 trials have been completed since 2018."
Answered by AI
Could you provide a number of hospitals or research centers where this trial is taking place?
"This study has many enrolling patients, 31 in total, from locations such as the Icahn School of Medicine at Mount Sinai in New york, UCSF Benioff Children's Hospital San Francisco in San Francisco, and University of Miami in Miami."
Answered by AI
Could you please explain the side effects of Odevixibat?
"Odevixibat's safety is considered to be good by our team at Power. This is because it is a Phase 3 trial, so there is already some data that suggests that it is effective and multiple rounds of data that supports its safety."
Answered by AI
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