NCT03659058

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Zagazig University · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fibrosis, Liver

Interventions

Type	Name	Description
DRUG	silymarin	silymarin 140 three times daily
DRUG	Ursodeoxycholic Acid	Ursodeoxycholic Acid 500
DRUG	Antioxidants	Beta Carotene - 6Mg Vitamin C - 200Mg Vitamin E - 50Mg
DRUG	Colchicine	Colchicine 0.6
OTHER	FOLLOW UP	follow up by abdominal ultrasound and fibroscan every 6 month for 1 year

Timeline

• Start date: 2016-03-02
• Primary completion: 2018-08-01
• Completion: 2018-08-01
• First posted: 2018-09-06
• Last updated: 2018-11-27