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

HCC in Chronic HCV Patients With Advanced Liver Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03884062
• Other study ID #: HCV-DAA
• Status: Completed
• Start date: June 1, 2015
• Est. completion date: January 1, 2019

Study information

• Verified date: March 2020
• Source: Egyptian Liver Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: January 1, 2019
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• HCC in Chronic HCV Patients With Advanced Liver Fibrosis
• Liver Cirrhosis

Intervention

Drug:
• DAAs
lab, U/S, Fibroscan & CT if needed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Egyptian Liver Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of HCC by CT	incidence of HCC in chronic hepatitis C patients with advanced liver fibrosis (F3 and F4) after achieving DAAs-SVR	12-45 months after SVR
Secondary	fibrosis stage changes by Fibroscan	post treatment fibrosis stage in chronic hepatitis C patients with advanced liver fibrosis (F3 and F4) after achieving DAAs-SVR	12-45 months after SVR