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Completed

NCT Number: NCT03884062

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

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

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Key information

Conditions

HCC in Chronic HCV Patients With Advanced Liver Fibrosis Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Fibrosis Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

DAAs

Drug

lab, U/S, Fibroscan & CT if needed

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Egyptian Liver Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Mar 21, 2019
Registry last updated
Mar 10, 2020

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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