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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Cholestasis||Drug: Lipanthyl Drug: Ursogal||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: Ursogal
Control group : Ursogal 10-20 mg/kg/d on 2 divided dose for four months with regular follow up.
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.
Other Name: ursogal
Other Name: non
- 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.
- 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
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
|Dr. Yassin Abdel Ghaffar Charity Center For Liver Diseases & Researches|
|Cairo, Nasr City, Egypt|
|National liver istitute|
|Shibīn Al Kawm, Egypt|
|Study Director:||Tawhida Y Abdel Ghaffar, MD||ASU|