Impact of Ursodeoxycholic Acid, Silymarin, Antioxidants and Colchicine on Fibrosis Regression in HCV After SVR
- Conditions
- Fibrosis, Liver
- Interventions
- Registration Number
- NCT03659058
- Lead Sponsor
- Zagazig University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- chronic HCV
- compensated liver disease (Child class A-B)
- sustained virological response
- liver stiffness by fibroscan >12.5 kPa denotes cirrhosis
- decompensated liver disease
- chronic active HCV
- hepatocellular carcinoma
- other liver diseases as alcoholic liver disease, autoimmune liver disease, drug-induced liver disease
- pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description study group Antioxidants 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 study group FOLLOW UP 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 control group FOLLOW UP 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 study group silymarin 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 study group Colchicine 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 study group Ursodeoxycholic Acid 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
- Primary Outcome Measures
Name Time Method Improved splenic stiffness measurement 1 year assessment by ultrasound and fibroscan
Improvement in liver stiffness measurement by Fibroscan 1 year Liver stiffness assessment by Fibroscan every 6 months
Improved portal hypertension parameters 1 year Assessment of portal vein diameter, splenic vein diameter, portal vein congestive index by ultrasound and Doppler every 6 months
- Secondary Outcome Measures
Name Time Method