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

Primary Purpose

Fibrosis, Liver

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
silymarin
Ursodeoxycholic Acid
Antioxidants
Colchicine
FOLLOW UP
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibrosis, Liver focused on measuring fibrosis, HCV, Reversal, sustained virological response

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    study group

    control group

    Arm 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

    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

    Outcomes

    Primary Outcome Measures

    Improvement in liver stiffness measurement by Fibroscan
    Liver stiffness assessment by Fibroscan every 6 months
    Improved portal hypertension parameters
    Assessment of portal vein diameter, splenic vein diameter, portal vein congestive index by ultrasound and Doppler every 6 months
    Improved splenic stiffness measurement
    assessment by ultrasound and fibroscan

    Secondary Outcome Measures

    Full Information

    First Posted
    August 6, 2018
    Last Updated
    November 23, 2018
    Sponsor
    Zagazig University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03659058
    Brief Title
    Impact of Ursodeoxycholic Acid, Silymarin, Antioxidants and Colchicine on Fibrosis Regression in HCV After SVR
    Acronym
    fib-reversal
    Official Title
    Impact of Ursodeoxycholic Acid, Silymarin, Antioxidants and Colchicine on Fibrosis Regression in HCV After Achieving Sustained Virological Response
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2, 2016 (Actual)
    Primary Completion Date
    August 2018 (Actual)
    Study Completion Date
    August 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Zagazig University

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fibrosis, Liver
    Keywords
    fibrosis, HCV, Reversal, sustained virological response

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    200 patients will receive silymarin 420 mg + antioxidants + colchicine
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    400 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    study group
    Arm Type
    Active Comparator
    Arm 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
    Arm Title
    control group
    Arm Type
    Placebo Comparator
    Arm 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
    Intervention Type
    Drug
    Intervention Name(s)
    silymarin
    Other Intervention Name(s)
    silymarin 140
    Intervention Description
    silymarin 140 three times daily
    Intervention Type
    Drug
    Intervention Name(s)
    Ursodeoxycholic Acid
    Other Intervention Name(s)
    ursofalk
    Intervention Description
    Ursodeoxycholic Acid 500
    Intervention Type
    Drug
    Intervention Name(s)
    Antioxidants
    Other Intervention Name(s)
    antox
    Intervention Description
    Beta Carotene - 6Mg Vitamin C - 200Mg Vitamin E - 50Mg
    Intervention Type
    Drug
    Intervention Name(s)
    Colchicine
    Intervention Description
    Colchicine 0.6
    Intervention Type
    Other
    Intervention Name(s)
    FOLLOW UP
    Other Intervention Name(s)
    ultrasound and fibroscan
    Intervention Description
    follow up by abdominal ultrasound and fibroscan every 6 month for 1 year
    Primary Outcome Measure Information:
    Title
    Improvement in liver stiffness measurement by Fibroscan
    Description
    Liver stiffness assessment by Fibroscan every 6 months
    Time Frame
    1 year
    Title
    Improved portal hypertension parameters
    Description
    Assessment of portal vein diameter, splenic vein diameter, portal vein congestive index by ultrasound and Doppler every 6 months
    Time Frame
    1 year
    Title
    Improved splenic stiffness measurement
    Description
    assessment by ultrasound and fibroscan
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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