Clinical trial
The Safety and Efficacy of Atorvastatin on Xanthoma in Alagille Syndrome
Name
ATO-ALGS-XAN
Description
To observe the efficacy and safety of atorvastatin on xanthoma in Alagille syndrome through a prospective study.
Trial arms
Trial start
2022-03-22
Estimated PCD
2025-03-22
Trial end
2025-03-22
Status
Recruiting
Phase
Early phase I
Treatment
atorvastatin
Oral atorvastatin treatment for ALGS children with xanthoma
Arms:
Atorvastatin+ALGS-Xanthoma
Other names:
Lipitor
Size
10
Primary endpoint
Grade change of xanthoma
from enrollment to the 3th/6th month
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ESTIMATED'}}
Updated at
2023-10-17
1 organization
1 product
3 indications
Organization
Children's Hospital of Fudan UniversityProduct
atorvastatinIndication
Alagille syndromeIndication
AtorvastatinIndication
Xanthoma