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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03659058
Acronym
fib-reversal
Enrollment
400
Registered
2018-09-06
Start date
2016-03-02
Completion date
2018-08-01
Last updated
2018-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibrosis, Liver

Keywords

fibrosis, HCV, Reversal, sustained virological response

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.

Interventions

DRUGsilymarin

silymarin 140 three times daily

DRUGUrsodeoxycholic Acid

Ursodeoxycholic Acid 500

DRUGAntioxidants

Beta Carotene - 6Mg Vitamin C - 200Mg Vitamin E - 50Mg

DRUGColchicine

Colchicine 0.6

OTHERFOLLOW UP

follow up by abdominal ultrasound and fibroscan every 6 month for 1 year

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

200 patients will receive silymarin 420 mg + antioxidants + colchicine

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Improvement in liver stiffness measurement by Fibroscan1 yearLiver stiffness assessment by Fibroscan every 6 months
Improved portal hypertension parameters1 yearAssessment of portal vein diameter, splenic vein diameter, portal vein congestive index by ultrasound and Doppler every 6 months
Improved splenic stiffness measurement1 yearassessment by ultrasound and fibroscan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026