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Maralixibat for Biliary Atresia (EMBARK Trial)
EMBARK Trial Summary
This trial will test if maralixibat is a safe and effective treatment for infants with biliary atresia after the Kasai procedure.
EMBARK Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowEMBARK Trial Timeline
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 • 93 Patients • NCT03905330EMBARK Trial Design
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Who is running the clinical trial?
Media Library
- I cannot tolerate feeding through my gut.I have been diagnosed with biliary atresia.I have had surgery to remove part of my ileum.My baby weighs at least 2500g, is older than 21 days but younger than 90 days at the time of their Kasai procedure.I have a liver condition that is not biliary atresia but affects my bile ducts.I have liver failure with significant fluid buildup.I had liver surgery or a Kasai procedure within the last 3 weeks.I have ongoing severe diarrhea that doesn't respond to treatment.I have been diagnosed with a rare liver or bile duct condition.
- Group 1: Placebo
- Group 2: Maralixibat
- 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
To what extent has this trial been disseminated across the country?
"This clinical trial is registering participants at Le Bonheur Children's Hospital in Memphis, The University of Chicago Medical Center in Illinois, and the Children's Hospital of Philadelphia in Pennsylvania amongst 8 other research centres."
Is the recruitment phase of this clinical trial still open?
"Affirmative, per the information located on clinicaltrials.gov this study is currently recruiting. This trial was initially shared on July 8th 2021 and most recently updated September 22nd 2022. 72 test subjects are being sought out from 8 distinct locations."
Could I potentially qualify to take part in this clinical exploration?
"Candidates interested in this clinical trial must suffer from biliary atresia, and their age needs to range between 21 days old and 111 days. 72 participants are needed for the study's completion."
Is this a pioneering research endeavor?
"At present, there are 4 active trials for Maralixibat located across 20 nations in 26 cities. The initial investigation into the drug was conducted by Mirum Pharmaceuticals Inc., concluding its Phase 2 trial with 52 participants back in 2019; since then, 18330 additional studies have been completed."
How many participants are currently taking part in this medical research?
"The research team at Mirum Pharmaceuticals, Inc. requires 72 suitable participants to conduct the clinical trial. Prospective patients can apply for inclusion from Le Bonheur Children's Hospital in Memphis and The University of Chicago Medical Center in Illinois."
Is the age restriction of this trial greater than two decades?
"This trial necessitates that patients who wish to enroll must be between 21 and 111 days old, in accordance with the set eligibility criteria."
Could you please describe any other trials which have used Maralixibat?
"Maralixibat was first studied by Hopital Necker-Enfants Malades in 2019 and since then 18330 clinical trials have been completed. Currently, 4 additional studies are underway with the majority of these being conducted from Memphis, Tennessee."
Has Maralixibat been given regulatory approval by the FDA?
"Given the Phase 2 status of Maralixibat's clinical trial, Power puts its safety rating at a conservative 2 since there is some data backing its security but none vouching for efficacy."
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