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

November 23, 2018 updated by: Amr Shaaban Hanafy, Zagazig University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: study group
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
Drug: silymarin
silymarin 140 three times daily
Other Names:
  • silymarin 140
Drug: Ursodeoxycholic Acid
Ursodeoxycholic Acid 500
Other Names:
  • ursofalk
Drug: Antioxidants
Beta Carotene - 6Mg Vitamin C - 200Mg Vitamin E - 50Mg
Other Names:
  • antox
Drug: Colchicine
Colchicine 0.6
Other: FOLLOW UP
follow up by abdominal ultrasound and fibroscan every 6 month for 1 year
Other Names:
  • ultrasound and fibroscan
Placebo Comparator: control group
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
Other: FOLLOW UP
follow up by abdominal ultrasound and fibroscan every 6 month for 1 year
Other Names:
  • ultrasound and fibroscan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in liver stiffness measurement by Fibroscan
Time Frame: 1 year
Liver stiffness assessment by Fibroscan every 6 months
1 year
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
1 year
Improved splenic stiffness measurement
Time Frame: 1 year
assessment by ultrasound and fibroscan
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2016

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

August 6, 2018

First Submitted That Met QC Criteria

September 1, 2018

First Posted (Actual)

September 6, 2018

Study Record Updates

Last Update Posted (Actual)

November 27, 2018

Last Update Submitted That Met QC Criteria

November 23, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 37801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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