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Pediatric Evaluation and Registry for Liver Cholestasis in Canada

Study acronym: PEARL
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Notable Lead sponsor: Children's Hospital of Eastern Ontario to Children's Hospital of Eastern Ontario Show 4 more changesShow less
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 41 words
    • Site details revised at 11 of 13 sites
    • Eligibility criteria expanded, about 4 words
  2. Notable Recruitment opened
    • Start date changed from estimate of Mar 2026 to Apr 21, 2026
    • Site details revised at 13 of 13 sites
    v4
  3. Minor Study sites revised (13)v3
  4. Minor Study description shortened, about 409 wordsv2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to create a national, multi-centre registry for children with Alagille syndrome (ALGS) and Genetic Intrahepatic Cholestasis (GIC) that follows participants long-term, ensuring standardized, high-quality data capture across all participating pediatric hepatology centres. Inclusion criteria: • Pediatric participants (\<18 years old) with genetically confirmed or clinically diagnosed ALGS or any of the various subtypes of GIC, each associated with a distinct genetic mutation: A. PFIC Type 1 (FIC1 Deficiency) - Mutation in ATP8B1 gene. B. PFIC Type 2 (BSEP Deficiency) - Mutation in ABCB11 gene. C. PFIC Type 3 (MDR3 Deficiency) - Mutation in ABCB4 gene. D. PFIC Type 4 (TJP2 Deficiency) - Mutation in TJP2 gene. E. PFIC Type 5 (FXR Deficiency) - Mutation in NR1H4 gene. F. PFIC Type 6 (MYO5B-Associated) - Mutation in MYO5B gene. G. Progressive cholestasis of northwestern Quebec (PCNQ)-Mutation in UTP4 gene. * Enrollment within Canadian pediatric liver centers participating in the registry. * Written informed consent obtained from participant if they have the capacity, or parents/guardians, and assent from participants as appropriate. Exclusion criteria: • Inability to comply with follow-up requirements (lost to follow-up). Participants will be recruited from our hepatology clinics retrospectively (diagnosed on or after January 1, 2022) and prospectively (newly diagnosed). Written consent/assent will be obtained from all participants prior to data collection from the participants' medical chart.
Trial Details
NCT Number NCT07411716
Lead Sponsor Children's Hospital of Eastern Ontario
Collaborators: Mirum Pharmaceuticals, Inc., medison pharma
Conditions
(from sponsor)
PFIC - Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome (ALGS), Cholestasis, Intrahepatic
Related terms Alagille Syndrome, Cholestasis, Cholestasis, Intrahepatic, Cholestasis, progressive familial intrahepatic 1
Enrollment 220 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov