Fibrates in Pediatric Cholestasis (NCT03586674) | Clinical Trial Compass
CompletedPhase 2
Fibrates in Pediatric Cholestasis
Egypt50 participantsStarted 2017-11-01
Plain-language summary
A study conducted to assess the effect of fibrates on pruritus and biochemical picture in pediatric patients with cholestatic liver diseases.
Who can participate
Age range
6 Months – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient with chronic cholestatic liver disease defined as any condition in which substances normally excreted into bile are retained for more than 6 months.
Exclusion Criteria:
* Patients with anatomical or mechanical obstructive causes for cholestasis.
* Cholestatic patients who were suffering from another liver disease.
* Cholestatic patients who were receiving drugs affecting lipid profile.
* Patients receiving drugs that interact with Fenofibrate (FF) e.g statins and warfarin
* Patients with non obstructive gall bladder stones were excluded from T gp.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested fibrates specifically for itching in children with chronic cholestasis — is my child's type of cholestasis similar enough to what was studied that the results might be relevant to us?
2Since this was a Phase 2 trial, what do the findings tell us about how well fibrates actually worked for reducing itching, and are there any safety signals we should know about before considering this type of treatment?
3The trial measured changes in a pruritus grading score — how is that kind of itch severity measured in practice, and how meaningful would the changes seen in the study be for my child's daily quality of life?
4Now that this trial is completed, has the data been published anywhere, and does it change what you would recommend for managing my child's cholestasis-related itching compared to what's currently standard of care?
5Are there other treatments for cholestasis-related itching in children that have more established safety and efficacy data, and how would you weigh those against what was studied in this fibrates trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.