|

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

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

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.