drugset / Trial / NCT03659058

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

NCT03659058

Completed 400 enrolled Zagazig University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2016-03-02
Primary completion
2018-08
Completion
2018-08-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Colchicine Small molecule 0.6 unknown
Comparator Silymarin Traditional medicine (herbal / TCM) 140 unknown
Comparator Ursodeoxycholic Acid Small molecule 500 unknown
Comparator Vitamin C Other / unclassified 200 mg
Comparator Vitamin E Other / unclassified 50 mg
Comparator beta-carotene Small molecule 6 mg