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

Fibrosis, Liver Clinical Trial

— fib-reversal  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03659058
• Other study ID #: 37801
• Status: Completed
• Phase: N/A
• Start date: March 2, 2016
• Est. completion date: August 1, 2018

Study information

• Verified date: November 2018
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: August 1, 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Fibrosis, Liver
• Liver Cirrhosis

Intervention

Drug:
• silymarin
silymarin 140 three times daily
• Ursodeoxycholic Acid
Ursodeoxycholic Acid 500
• Antioxidants
Beta Carotene - 6Mg Vitamin C - 200Mg Vitamin E - 50Mg
• Colchicine
Colchicine 0.6

Other:
• FOLLOW UP
follow up by abdominal ultrasound and fibroscan every 6 month for 1 year

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in liver stiffness measurement by Fibroscan	Liver stiffness assessment by Fibroscan every 6 months	1 year
Primary	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
Primary	Improved splenic stiffness measurement	assessment by ultrasound and fibroscan	1 year