Fibrates in Pediatric Cholestasis

July 14, 2018 updated by: Hoda A. Atta

Fibrates: An Adjuvant Therapy for Cholestasis In Pediatric Age Group

A study conducted to assess the effect of fibrates on pruritus and biochemical picture in pediatric patients with cholestatic liver diseases.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cholestatic liver disorders include a spectrum of hepatobiliary diseases of diverse etiologies that are characterized by impaired hepatocellular secretion of bile, resulting in accumulation of bile acids, bilirubin and cholesterol.This could result in different clinical features including pruritus, malabsorption and vitamin deficiencies with subsequent coagulation disorders and bone disease. Persistence of cholestasis leads to biliary fibrosis which can progress to liver cirrhosis and end-stage liver disease.

Nuclear receptors (NRs) regulate ligand-activated transcription factor networks of genes for the elimination and detoxification of potentially toxic biliary constituents accumulating in cholestasis. Activation of several NRs also modulates fibrogenesis, inflammation, and carcinogenesis as sequelae of cholestasis. Hence, It represent attractive targets for pharmacotherapy of cholestatic disorders.

Several already available drugs may exert their beneficial effects in cholestasis via NR activation eg, ursodeoxycholic acid via glucocorticoid receptor and pregnane X receptor, and rifampicin via pregnane X receptor. Unfortunately, Some patients may not respond to these medications.

Fibrates, serum Lipid lowering medication, has a stimulation action on proliferator activated receptor alpha. It is a nuclear receptor with an integral role in bile homeostasis. Several case reports and pilot studies have demonstrated the efficacy of fibrates in reducing serum biomarkers of cholestasis and liver function abnormalities in patients with incomplete response to ursodeoxycholic acid monotherapy. These results are of interest, because fibrates are attracting increased attention as adjunct therapy for chronic cholestatic liver diseases.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Shibīn Al Kawm, Egypt
        • National liver istitute
    • Nasr City
      • Cairo, Nasr City, Egypt
        • Dr. Yassin Abdel Ghaffar Charity Center For Liver Diseases & Researches

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ursogal
Control group : Ursogal 10-20 mg/kg/d on 2 divided dose for four months with regular follow up.
Drug: Ursogal
suspension
Other Names:
  • non
Experimental: Lipanthyl + Ursogal
Therapy group: Ursogal 10-20 mg/kg/d by mouth, on 2 divided dose, and lipanthyl 10-20 mg/kg/d by mouth,once per day, for four months with regular follow up.
Drug: Ursogal
suspension
Other Names:
  • non
Drug: Lipanthyl
Tablet
Other Names:
  • ursogal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the pruritus grading score
Time Frame: four months
The pruritus grading score includes four areas each has its score: distribution score 1-3;1= single site and 3 generalized, Severity score 1-5 ; 1= rubbing,5 = general excoriation, Frequency score 1-5; 1= episodic,5= continuous, and Sleep disturbance score 0-6 ; 0= no effect on sleep, 6= total restless.
four months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the liver function test and lipid profile
Time Frame: four months
investigate the effect on Alanine Aminotransferase (ALT),Aspartate Aminotransferase (AST) ,Albumin,Bilirubin, Bile acid, lipid profile
four months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoda A. Atta

Investigators

  • Study Director: Tawhida Y Abdel Ghaffar, MD, ASU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 20, 2018

Study Registration Dates

First Submitted

July 2, 2018

First Submitted That Met QC Criteria

July 2, 2018

First Posted (Actual)

July 13, 2018

Study Record Updates

Last Update Posted (Actual)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 14, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1984

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only overall results will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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