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Fibrates in Pediatric Cholestasis

Primary Purpose

Chronic Cholestasis

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Lipanthyl
Ursogal
Sponsored by
Hoda A. Atta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Cholestasis focused on measuring pediatric cholestasis, Fibrate

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dr. Yassin Abdel Ghaffar Charity Center For Liver Diseases & Researches
  • National liver istitute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ursogal

Lipanthyl + Ursogal

Arm Description

Control group : Ursogal 10-20 mg/kg/d on 2 divided dose for four months with regular follow up.

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.

Outcomes

Primary Outcome Measures

Change in the pruritus grading score
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

Changes in the liver function test and lipid profile
investigate the effect on Alanine Aminotransferase (ALT),Aspartate Aminotransferase (AST) ,Albumin,Bilirubin, Bile acid, lipid profile

Full Information

First Posted
July 2, 2018
Last Updated
July 14, 2018
Sponsor
Hoda A. Atta
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1. Study Identification

Unique Protocol Identification Number
NCT03586674
Brief Title
Fibrates in Pediatric Cholestasis
Official Title
Fibrates: An Adjuvant Therapy for Cholestasis In Pediatric Age Group
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hoda A. Atta

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Cholestasis
Keywords
pediatric cholestasis, Fibrate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ursogal
Arm Type
Active Comparator
Arm Description
Control group : Ursogal 10-20 mg/kg/d on 2 divided dose for four months with regular follow up.
Arm Title
Lipanthyl + Ursogal
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lipanthyl
Other Intervention Name(s)
ursogal
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
Ursogal
Other Intervention Name(s)
non
Intervention Description
suspension
Primary Outcome Measure Information:
Title
Change in the pruritus grading score
Description
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.
Time Frame
four months
Secondary Outcome Measure Information:
Title
Changes in the liver function test and lipid profile
Description
investigate the effect on Alanine Aminotransferase (ALT),Aspartate Aminotransferase (AST) ,Albumin,Bilirubin, Bile acid, lipid profile
Time Frame
four months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tawhida Y Abdel Ghaffar, MD
Organizational Affiliation
ASU
Official's Role
Study Director
Facility Information:
Facility Name
Dr. Yassin Abdel Ghaffar Charity Center For Liver Diseases & Researches
City
Cairo
State/Province
Nasr City
Country
Egypt
Facility Name
National liver istitute
City
Shibīn Al Kawm
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Only overall results will be shared.
Citations:
PubMed Identifier
23174993
Citation
Ghonem NS, Boyer JL. Fibrates as adjuvant therapy for chronic cholestatic liver disease: its time has come. Hepatology. 2013 May;57(5):1691-3. doi: 10.1002/hep.26155. Epub 2013 Apr 5. No abstract available.
Results Reference
background
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4048949/
Description
Review article

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Fibrates in Pediatric Cholestasis

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