CompletedPhase 2

Evaluation of Maralixibat in Biliary Atresia Response Post-Kasai

United States75 participantsStarted 2021-07-08

Plain-language summary

A study to evaluate the efficacy and safety of maralixibat in infants with Biliary Atresia (BA) after Hepatoportoenterostomy (HPE, also known as the Kasai procedure).

Who can participate

Age range21 Days – 111 Days

SexALL

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Inclusion criteria

✓. Male or female subjects with body weight ≥2500 g, who are ≥21 days old and \<90 days old at the time of HPE (Kasai)
✓. HPE or Kasai Procedure within 3 weeks prior to randomization
✓. Clinical diagnosis of biliary atresia

Exclusion criteria

✕. Subjects with intractable chronic diarrhea at randomization
✕. Subjects not tolerating enteral feeds at randomization
✕. History of ileal resection
✕. Diagnosis of biliary atresia splenic malformation syndrome or cystic biliary atresia
✕. Evidence of another non-biliary atresia pathology involving the intrahepatic bile duct (e.g., paucity, sclerosing cholangitis)
✕. Evidence of liver failure (e.g. significant ascites)

What they're measuring

Mean Change in Total Serum Bilirubin Levels

Timeframe: From baseline to Week 26

Trial details

NCT IDNCT04524390

SponsorMirum Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-07

Results submitted2024-12-20

View on ClinicalTrials.gov More Biliary Atresia trials