Fibrates in Pediatric Cholestasis

NCT03586674 | Completed Phase 2 DMC

• 1 other identifier: 1984
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Chronic Cholestasis

Keywords

pediatric cholestasis, Fibrate

Outcome Measures

Primary Outcomes (1)

• 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.

  four months

Secondary Outcomes (1)

• Changes in the liver function test and lipid profile

  four months

Study Arms (2)

Ursogal

ACTIVE COMPARATOR

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

Drug: Ursogal

Lipanthyl + Ursogal

EXPERIMENTAL

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; Drug: Ursogal

Interventions

Lipanthyl DRUG

Tablet

Also known as: ursogal

Lipanthyl + Ursogal

Ursogal DRUG

suspension

Also known as: non

Lipanthyl + Ursogal; Ursogal

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patient with chronic cholestatic liver disease defined as any condition in which substances normally excreted into bile are retained for more than 6 months.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoda A. Atta: lead

Study Sites (2)

Dr. Yassin Abdel Ghaffar Charity Center For Liver Diseases & Researches

Cairo, Nasr City, Egypt

Location

National liver istitute

Shibīn al Kawm, Egypt

Location

Related Publications (1)

• 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.

  PMID: 23174993 BACKGROUND

Related Links

• Review article

MeSH Terms

Interventions

Fenofibrate; Ursodeoxycholic Acid

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones; Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• Tawhida Y Abdel Ghaffar, MD

  ASU

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pediatric Specialist

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 13, 2018
• Study Start: November 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 20, 2018
• Last Updated: July 17, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)