This study is currently not recruiting participants.

The Evaluation of the Intestinal Bile Acid Transport (IBAT) Inhibitor LUM001 in the Reduction of Pruritus in Alagille Syndrome a Cholestatic Liver Disease

Study on the Effects of an Investigational Medication on Itching in Children with Alagille Syndrome

Not Recruiting
1 years - 18 years
All
Phase N/A
1 Location

Brief description of study.

The purpose of this study is to evaluate the effect of LUM001 compared to placebo (looks like medicine but does not contain any medicine) on pruritus (itching) in children with Alagille Syndrome.

Detailed description of study

The purpose of this study to investigate the effects of LUM001 compared to placebo on pruritus, serum bile acids, liver enzymes and other biochemical markers associated with cholestatic liver disease, during daily dosing over a 13 week period.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Alagille syndrome
  • Age: 1 years - 18 years
  • Gender: All

The purpose of this study is to evaluate the effect of an investigational medication compared to a placebo on itching in children with Alagille Syndrome. Alagille Syndrome is a genetic disorder that affects the liver, heart, and other parts of the body and can cause itching due to liver problems.

Participants will receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. The study will assess changes in itching, serum bile acids, liver enzymes, and other biochemical markers related to cholestatic liver disease over a 13-week period.

  • Who can participate: Children aged 2 to 18 years with a diagnosis of Alagille Syndrome experiencing moderate to severe itching are eligible to participate. Key eligibility factors include stable liver function and no recent participation in other clinical trials.
  • Study details: Participants will take the investigational medication or placebo daily to see how it affects itching and various liver-related markers.
  • Study Timelines: The study will last 13 weeks.
Updated on 19 Feb 2024. Study ID: 1402600890

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