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Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)

Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in children with biliary atresia who have undergone a Kasai hepatoportoenterostomy.

Stanford is currently accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: Odevixibat
  • drug: Placebo

Eligibility


Inclusion Criteria:

   - A male or female patient with a clinical diagnosis of BA

   - Age at Kasai HPE ≤90 days

   - Eligible to start study treatment within 3 weeks post-Kasai HPE

Key Exclusion Criteria:

   - Patients with intractable ascites

   - Ileal resection surgery

   - ALT ≥10× upper limit of normal (ULN) at screening

   - Patients reliant only on total parenteral nutrition, or not able to take study
   medication orally, at randomization

   - Acute ascending cholangitis (patients may be randomized after resolution of acute
   ascending cholangitis)

   - Choledochal cystic disease

   - 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)

   - 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

   - Weight <3.5kg at randomization

Ages Eligible for Study

N/A - 111 Days

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Amrita Narang, MD
Recruiting