Impact of Ursodeoxycholic Acid, Silymarin, Antioxidants and Colchicine on Fibrosis Regression in HCV After SVR (fib-reversal)

Zagazig University

Status: Completed

Conditions: Fibrosis, Liver

Treatments: Drug: Ursodeoxycholic Acid; Other: FOLLOW UP; Drug: silymarin; Drug: Antioxidants; Drug: Colchicine

Study type: Interventional

Funder types: Other

Identifiers

NCT03659058

37801

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups, including a placebo group

study group

Active Comparator group

Description:

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

Treatment:

Drug: Antioxidants

Drug: silymarin

Other: FOLLOW UP

Drug: Ursodeoxycholic Acid

Drug: Colchicine

control group

Placebo Comparator group

Description:

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

Treatment:

Other: FOLLOW UP