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Fibrates in Pediatric Cholestasis

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ClinicalTrials.gov Identifier: NCT03586674
Recruitment Status : Completed
First Posted : July 13, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Hoda A. Atta, Ministry of Health and Population, Egypt

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
Chronic Cholestasis Drug: Lipanthyl Drug: Ursogal 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.


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Study Type : Interventional  (Clinical Trial)
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 : November 1, 2017
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : June 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching

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 Name: 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 Name: ursogal

Drug: Ursogal
suspension
Other Name: non




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03586674


Locations
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Egypt
Dr. Yassin Abdel Ghaffar Charity Center For Liver Diseases & Researches
Cairo, Nasr City, Egypt
National liver istitute
Shibīn Al Kawm, Egypt
Sponsors and Collaborators
Hoda A. Atta
Investigators
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Study Director: Tawhida Y Abdel Ghaffar, MD ASU

Additional Information:
Publications:
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Responsible Party: Hoda A. Atta, Pediatric Specialist, Ministry of Health and Population, Egypt
ClinicalTrials.gov Identifier: NCT03586674     History of Changes
Other Study ID Numbers: 1984
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only overall results will be shared.

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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, Ministry of Health and Population, Egypt:
pediatric cholestasis, Fibrate

Additional relevant MeSH terms:
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Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Clofibric Acid
Fenofibrate
Ursodeoxycholic Acid
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Cholagogues and Choleretics
Gastrointestinal Agents