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Atorvastatin Therapy on Xanthoma in Alagille Syndrome
RECRUITINGPhase 4Sponsored by Children's Hospital of Fudan University
Actively Recruiting
PhasePhase 4
SponsorChildren's Hospital of Fudan University
Started2022-03-22
Est. completion2025-03-22
Eligibility
Age1 Day – 17 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05488067
Summary
To observe the efficacy and safety of atorvastatin on xanthoma in Alagille syndrome through a prospective study.
Eligibility
Age: 1 Day – 17 YearsHealthy volunteers accepted
Inclusion Criteria: * Meet the ALGS diagnostic criteria; * Xanthoma of skin; * Before treatment with atorvastatin,non-HDL-C≥5.76mmol/L(223 mg/dL); * Informed consent; * Age 0-17 years old, male or female; * Taking bile acid chelator (colenemide) has no obvious effect or intolerance. Exclusion Criteria: * Liver transplantation has been performed; * In the recovery period of cholestasis, xanthoma is obviously subsiding; * Patients with serious systemic diseases and unstable vital signs; * Progressive active liver injury, such as continuous increase of transaminase; * Serious myopathy; * Known to be allergic to any component of atorvastatin; * The weight is less than 5kg.
Conditions5
Alagille SyndromeAtorvastatinHeart DiseaseLiver DiseaseXanthoma
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Actively Recruiting
PhasePhase 4
SponsorChildren's Hospital of Fudan University
Started2022-03-22
Est. completion2025-03-22
Eligibility
Age1 Day – 17 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05488067