Atorvastatin Therapy on Xanthoma in Alagille Syndrome (NCT05488067) | Clinical Trial Compass
CompletedPhase 4
Atorvastatin Therapy on Xanthoma in Alagille Syndrome
China15 participantsStarted 2022-03-22
Plain-language summary
To observe the efficacy and safety of atorvastatin on xanthoma in Alagille syndrome through a prospective study.
Who can participate
Age range1 Day – 17 Years
SexALL
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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.