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OpenTrials
Completed

NCT Number: NCT03659058

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

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.

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Key information

Conditions

Fibrosis, Liver Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Silymarin

Drug

silymarin 140 three times daily

Other names: silymarin 140

Ursodeoxycholic acid

Drug

Ursodeoxycholic Acid 500

Other names: ursofalk

Antioxidants

Drug

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

Other names: antox

Colchicine

Drug

Colchicine 0.6

Follow up

Other

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

Other names: ultrasound and fibroscan

Primary outcomes

  1. Improvement in liver stiffness measurement by Fibroscan

    Time frame: 1 year

    Liver stiffness assessment by Fibroscan every 6 months

  2. Improved portal hypertension parameters

    Time frame: 1 year

    Assessment of portal vein diameter, splenic vein diameter, portal vein congestive index by ultrasound and Doppler every 6 months

  3. Improved splenic stiffness measurement

    Time frame: 1 year

    assessment by ultrasound and fibroscan

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Acronym: fib-reversal

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 6, 2018
Registry last updated
Nov 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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