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Clinical Impacts of Achieving SVR in Patients With Advanced Hepatic Fibrosis Related to Chronic HCV Treated With Direct Acting Antivirals

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ClinicalTrials.gov Identifier: NCT03884062
Recruitment Status : Completed
First Posted : March 21, 2019
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Egyptian Liver Hospital

Study Description
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Brief Summary:
Chronic HCV infection has relatively slow rate of progression. Liver fibrosis is the main sequlae and usually progressed to cirrhosis after long period (10 to 20 years) [6]. Once cirrhosis is established the disease progression remains unpredictable: cirrhosis can remain indolent for many years in some patients whilst progressing in others to HCC, hepatic decompensation and death. Overall once cirrhosis has developed there is a 1-5% annual risk of HCC and a 3-6% annual risk of hepatic decompensation. Following an episode of decompensation the risk of death in the following year is between 15% and 20% Treatment of chronic HCV has been dramatically changed in the last few years with introduction of direct acting antivirals (DAAs). The new therapies with excellent safety profiles, shorter duration of therapy and marked higher efficacy can be even used in patients with advanced fibrosis and cirrhosis

Condition or disease Intervention/treatment
HCC in Chronic HCV Patients With Advanced Liver Fibrosis Drug: DAAs

Detailed Description:
Chronic HCV infection has relatively slow rate of progression. Liver fibrosis is the main sequlae and usually progressed to cirrhosis after long period (10 to 20 years) [6]. Once cirrhosis is established the disease progression remains unpredictable: cirrhosis can remain indolent for many years in some patients whilst progressing in others to HCC, hepatic decompensation and death. Overall once cirrhosis has developed there is a 1-5% annual risk of HCC and a 3-6% annual risk of hepatic decompensation. Following an episode of decompensation the risk of death in the following year is between 15% and 20% Treatment of chronic HCV has been dramatically changed in the last few years with introduction of direct acting antivirals (DAAs). The new therapies with excellent safety profiles, shorter duration of therapy and marked higher efficacy can be even used in patients with advanced fibrosis and cirrhosis
Study Design
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Study Type : Observational
Actual Enrollment : 3000 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Clinical Impacts of Achieving Sustained Virological Response in Patients With Advanced Hepatic Fibrosis Related to Chronic HCV Treated With Direct Acting Antivirals
Actual Study Start Date : June 1, 2015
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
DAAs-SVR.
annual incidence of HCC in chronic hepatitis C patients with advanced liver fibrosis (F3 and F4) after achieving DAAs-SVR.
 Drug: DAAs
lab, U/S, Fibroscan & CT if needed


Outcome Measures
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Primary Outcome Measures :
  1. Detection of HCC by CT [ Time Frame: 12-45 months after SVR ]
    incidence of HCC in chronic hepatitis C patients with advanced liver fibrosis (F3 and F4) after achieving DAAs-SVR


Secondary Outcome Measures :
  1. fibrosis stage changes by Fibroscan [ Time Frame: 12-45 months after SVR ]
    post treatment fibrosis stage in chronic hepatitis C patients with advanced liver fibrosis (F3 and F4) after achieving DAAs-SVR


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all subjects from screening with positive HCV whom received treatment for 12/24 week with DAAs
Criteria

Inclusion Criteria:

  • above 12 years old
  • fibroscan F3 or F4
  • HCV positive
  • Received DAAs

Exclusion Criteria:

  • below 12 years old
  • fibroscan below F3
  • HCV negative
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Egyptian Liver Hospital
ClinicalTrials.gov Identifier: NCT03884062    
Other Study ID Numbers: HCV-DAA
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Egyptian Liver Hospital:
HCC, chronic hepatitis C, hepatitis C, liver fibrosis
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases