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

NCT03884062 | Completed

• 1 other identifier: HCV-DAA
• Study Type: observational
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

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

Conditions

HCC in Chronic HCV Patients With Advanced Liver Fibrosis

Keywords

HCC, chronic hepatitis C, hepatitis C, liver fibrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• fibrosis stage changes by Fibroscan

  12-45 months after SVR

Study Arms (1)

DAAs-SVR.

annual incidence of HCC in chronic hepatitis C patients with advanced liver fibrosis (F3 and F4) after achieving DAAs-SVR.

Drug: DAAs

Interventions

DAAs DRUG

lab, U/S, Fibroscan \& CT if needed

DAAs-SVR.

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all subjects from screening with positive HCV whom received treatment for 12/24 week with DAAs

You may qualify if:

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

You may not qualify if:

• below 12 years old
• fibroscan below F3
• HCV negative

Sponsors & Collaborators

• Egyptian Liver Hospital: lead

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 21, 2019
• Study Start: June 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: January 1, 2019
• Last Updated: March 10, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share