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Can a common cholesterol drug shrink skin lumps in kids with rare liver disease?

NCT ID NCT05488067

Disease control Sponsor: Children's Hospital of Fudan University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested the safety and effectiveness of atorvastatin (Lipitor) in 15 children with Alagille syndrome who had skin cholesterol deposits called xanthomas. The children took the drug for 6 months, and doctors graded the size and number of the lumps. The goal was to see if the drug could reduce these deposits without causing serious side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
atorvastatin (Lipitor)
What this could lead to
If it works, this could offer a way to shrink or prevent disfiguring skin cholesterol lumps in children with Alagille syndrome.
What could go wrong
This is a very small, single-center study with only 15 children. The results may not apply to all patients, and statins can cause muscle pain or liver issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

15 people

The number who actually took part.

Started

Mar 2022

Finished

Aug 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 day to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Alagille syndrome xanthoma xanthomatosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alagille syndrome Atorvastatin Xanthoma

Contacts and locations

Locations

  • Children's Hospital of Fudan University

    Shanghai, Shanghai Municipality, 201102, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.