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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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 52 Patients • NCT04674761Trial Design
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- 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.
- Group 1: Odevixibat (A4250)
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
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."
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."
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."
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."
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."
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