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Fibrates in Pediatric Cholestasis

Sponsor
Hoda A. Atta (Other)
Overall Status
Completed
CT.gov ID
NCT03586674
Collaborator
(none)
50
Enrollment
2
Locations
2
Arms
7.6
Actual Duration (Months)
25
Patients Per Site
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Fibrates: An Adjuvant Therapy for Cholestasis In Pediatric Age Group
Actual Study Start Date :
Nov 1, 2017
Actual Primary Completion Date :
Jun 1, 2018
Actual Study Completion Date :
Jun 20, 2018

Arms and Interventions

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: Lipanthyl
    Tablet
    Other Names:
  • ursogal

    • Drug: Ursogal
    suspension
    Other Names:
  • non

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in the pruritus grading score [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.

    Secondary Outcome Measures

    1. Changes in the liver function test and lipid profile [four months]

      investigate the effect on Alanine Aminotransferase (ALT),Aspartate Aminotransferase (AST) ,Albumin,Bilirubin, Bile acid, lipid profile

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dr. Yassin Abdel Ghaffar Charity Center For Liver Diseases & Researches Cairo Nasr City Egypt
    2 National liver istitute Shibīn Al Kawm Egypt

    Sponsors and Collaborators

    • Hoda A. Atta

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Hoda A. Atta, Pediatric Specialist, Ministry of Health and Population, Egypt
    ClinicalTrials.gov Identifier:
    NCT03586674
    Other Study ID Numbers:
    • 1984
    First Posted:
    Jul 13, 2018
    Last Update Posted:
    Jul 17, 2018
    Last Verified:
    Jul 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Hoda A. Atta, Pediatric Specialist, Ministry of Health and Population, Egypt
    pediatric cholestasis, Fibrate
    Additional relevant MeSH terms:
    Cholestasis
    Ursodeoxycholic Acid
    Fenofibrate

    Study Results

    No Results Posted as of Jul 17, 2018