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This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia Who Have Undergone a Kasai HPE
EU CTIS ID: 2024-512086-14-00
What this study is testing
The primary objective is to evaluate the efficacy of repeated once-daily doses of odevixibat versus placebo in children with biliary atresia (BA) post Kasai hepatoportoenterostomy(HPE) based native liver survival (NLS) of up to 104 weeks.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. A male or female patient with a clinical diagnosis of BA
- 2. Age at Kasai HPE ≤90 days
- 3. Eligible to start treatment within 3 weeks post-Kasai HPE
You likely can't join if
- 1. Patients with intractable ascites
- 2. Ileal resection surgery
- 3. ALT ≥10× upper limit of normal (ULN) at screening
- 4. Patient on total parenteral nutrition, or not able to take study drug orally, at randomization
- 5. Acute ascending cholangitis (patients may be randomized after resolution of acute ascending cholangitis)
- 6. Choledochal cystic disease
See the full eligibility criteria
- 1. A male or female patient with a clinical diagnosis of BA
- 2. Age at Kasai HPE ≤90 days
- 3. Eligible to start treatment within 3 weeks post-Kasai HPE
- 1. Patients with intractable ascites
- 2. Ileal resection surgery
- 3. ALT ≥10× upper limit of normal (ULN) at screening
- 4. Patient on total parenteral nutrition, or not able to take study drug orally, at randomization
- 5. Acute ascending cholangitis (patients may be randomized after resolution of acute ascending cholangitis)
- 6. Choledochal cystic disease
- 7. INR >1.6 (the patient may be treated with Vitamin K intravenously; sample may be redrawn and if INR is ≤1.6 at resampling the patient may be randomized)
- 8. Any other conditions or abnormalities, including congenital abnormalities, major cardiac surgery, hepatic, biliary, or GI disease which, in the opinion of the Investigator or Medical Monitor, may compromise the safety of the patient, the integrity of study results, or patient compliance with study requirements
- 9. Weight < 3.5kg at randomization
The study team makes the final eligibility decision.
Where it's taking place
- New Zealand
- Canada
- Taiwan
- United Kingdom
- China
- Australia
- Turkey
- Israel
- Malaysia
- Korea, Republic of
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Zealand; Canada; Taiwan; United Kingdom; China; Australia and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.