Atorvastatin Therapy on Xanthoma in Alagille Syndrome

• Status: Recruiting
• Trial end date: 2025-03-22
• Target enrollment: 0
• Participant gender: All

Summary

To observe the efficacy and safety of atorvastatin on xanthoma in Alagille syndrome through a prospective study.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Fudan University
• Treatments: Atorvastatin

Criteria

Inclusion Criteria:

• Meet the ALGS diagnostic criteria;

• Xanthoma of skin; ③ Before treatment with atorvastatin, LDL-C≥4.9mmol/L（190 mg/dL）； ④ Informed consent; ⑤ 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;

④ Progressive active liver injury, such as continuous increase of transaminase;

• Serious myopathy;

⑥ Known to be allergic to any component of atorvastatin.