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Study identifier: NCT07411716 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Pediatric Evaluation and Registry for Liver Cholestasis in Canada

Condition: PFIC - Progressive Familial Intrahepatic Cholestasis · Alagille Syndrome (ALGS) · Cholestasis, Intrahepatic  ·  Sponsor: Children's Hospital of Eastern Ontario

PhaseN/A
Planned participants220
Who can joinAll sexes, N/A to 18 Years
Healthy volunteersNo

About this study

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 col…

This description comes directly from the study's public registry record.

Talk to the study team

Mohit Kehar  ·  613-737-7600 x 1516  ·  MKehar@cheo.on.ca

Always discuss trial participation with your own doctor first.

Locations (13)

Alberta Children's HospitalCalgary, Alberta, CanadaNot Yet Recruiting
Stollery Children's HospitalEdmonton, Alberta, CanadaNot Yet Recruiting
BC Children's HospitalVancouver, British Columbia, CanadaNot Yet Recruiting
HSC Winnipeg Children's HospitalWinnipeg, Manitoba, CanadaNot Yet Recruiting
Janeway Children's Health and Rehabilitation CentreSt. John's, Newfoundland and Labrador, CanadaNot Yet Recruiting
Children's Hospital IWK Health CentreHalifax, Nova Scotia, CanadaNot Yet Recruiting
McMaster Children's HospitalHamilton, Ontario, CanadaNot Yet Recruiting
Children's Hospital LHSCLondon, Ontario, CanadaNot Yet Recruiting
Children's Hospital of Eastern OntarioOttawa, Ontario, CanadaRecruiting
CHU Sainte-JustineMontreal, Quebec, CanadaNot Yet Recruiting
Montreal Children's HospitalMontreal, Quebec, CanadaNot Yet Recruiting
CHU de Quebec - Universite Laval (Centre Mere-Enfant Soleil)Qubec City, Quebec, CanadaNot Yet Recruiting

+ 1 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07411716