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

Sponsor
Zagazig University (Other)
Overall Status
Completed
CT.gov ID
NCT03659058
Collaborator
(none)
400
Enrollment
2
Arms
29
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
200 patients will receive silymarin 420 mg + antioxidants + colchicine200 patients will receive silymarin 420 mg + antioxidants + colchicine
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Impact of Ursodeoxycholic Acid, Silymarin, Antioxidants and Colchicine on Fibrosis Regression in HCV After Achieving Sustained Virological Response
Actual Study Start Date :
Mar 2, 2016
Actual Primary Completion Date :
Aug 1, 2018
Actual Study Completion Date :
Aug 1, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Improvement in liver stiffness measurement by Fibroscan [1 year]

      Liver stiffness assessment by Fibroscan every 6 months

    2. Improved portal hypertension parameters [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 [1 year]

      assessment by ultrasound and fibroscan

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Zagazig University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amr Shaaban Hanafy, Assistant professor of medicine, Zagazig University
    ClinicalTrials.gov Identifier:
    NCT03659058
    Other Study ID Numbers:
    • 37801
    First Posted:
    Sep 6, 2018
    Last Update Posted:
    Nov 27, 2018
    Last Verified:
    Nov 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Amr Shaaban Hanafy, Assistant professor of medicine, Zagazig University
    fibrosis
    HCV
    Reversal
    sustained virological response
    Additional relevant MeSH terms:
    Liver Cirrhosis
    Fibrosis
    Colchicine
    Ursodeoxycholic Acid
    Antioxidants
    Silymarin

    Study Results

    No Results Posted as of Nov 27, 2018