Impact of Ursodeoxycholic Acid, Silymarin, Antioxidants and Colchicine on Fibrosis Regression in HCV After SVR

Study Overview
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Brief Summary
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with the introduction of Direct-acting antiviral agents in the management of HCV, the scope of inclusion criteria had been widened to include patients with compensated cirrhosis and even in special situations patients with decompensated liver disease; a chance that was not offered by the limited and strict inclusion criteria needed for treatment by pegylated interferon-based regimen. this made the number of patients with progressive liver fibrosis of cirrhosis had been inv=creased even after achieving SVR. the debate about the impact of SVR on halting fibrosis progression had risen; some studies postulated that patients benefit from an SVR through reduction of mortality, morbidity, and improved quality of life ; however, some patients may maintain their level of fibrosis or even progress to cirrhosis despite achieving SVR and the risk for HCC remains even after virologic eradication.

Official Title
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Impact of Ursodeoxycholic Acid, Silymarin, Antioxidants and Colchicine on Fibrosis Regression in HCV After Achieving Sustained Virological Response

Conditions
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Fibrosis, Liver

Intervention / Treatment
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* Drug: silymarin
* Drug: Ursodeoxycholic Acid
* Drug: Antioxidants
* Drug: Colchicine
* Other: FOLLOW UP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic HCV compensated liver disease (Child class A-B) sustained virological response liver stiffness by fibroscan >12.5 kPa denotes cirrhosis Exclusion Criteria: decompensated liver disease chronic active HCV hepatocellular carcinoma other liver diseases as alcoholic liver disease, autoimmune liver disease, drug-induced liver disease pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 200 patients will receive silymarin 420 mg + antioxidants + colchicine
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: study group<br>200 patients with compensated liver cirrhosis (F4) by fibroscan; Child Turcotte Pugh score A, after achieving sustained virological response will be treated by anti-fibrotic agents | Drug: silymarin<br>* silymarin 140 three times daily<br>* Other names: silymarin 140;Drug: Ursodeoxycholic Acid<br>* Ursodeoxycholic Acid 500<br>* Other names: ursofalk;Drug: Antioxidants<br>* Beta Carotene - 6Mg Vitamin C - 200Mg Vitamin E - 50Mg<br>* Other names: antox;Drug: Colchicine<br>* Colchicine 0.6<br>Other: FOLLOW UP<br>* follow up by abdominal ultrasound and fibroscan every 6 month for 1 year<br>* Other names: ultrasound and fibroscan;|
| Placebo Comparator: control group<br>200 patients with compensated liver cirrhosis (F4) by fibroscan; Child Turcotte Pugh score A, after achieving sustained virological response will be followed up without any intervention | Other: FOLLOW UP<br>* follow up by abdominal ultrasound and fibroscan every 6 month for 1 year<br>* Other names: ultrasound and fibroscan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in liver stiffness measurement by Fibroscan | Liver stiffness assessment by Fibroscan every 6 months | 1 year | 
| Improved portal hypertension parameters | Assessment of portal vein diameter, splenic vein diameter, portal vein congestive index by ultrasound and Doppler every 6 months | 1 year | 
| Improved splenic stiffness measurement | assessment by ultrasound and fibroscan | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCV, fibrosis, Reversal, sustained virological response