Long Term Follow up of Chronic HCV Patients Receiving DAAS

• Conditions: Chronic Hepatitis c

• Registration Number: NCT05170490
• Lead Sponsor: Sohag University

Brief Summary

Follow up of Chronic hepatitis C Patients with moderate to severe fibrosis and cirrhosis treated with Direct Acting Antivirals after Sustained Virological Response for 4-5 years to detect changes in hepatic fibrosis and liver functions.

Detailed Description

Treatment of chronic hepatitis C is evolving rapidly. Three classes of direct-acting antiviral agents, including inhibitors of the HCV NS3/4A protease, NS5B polymerase, and NS5A have been approved for the treatment of patients with chronic hepatitis C, both in combination with pegylated Interferon (Peg-IFN) / ribavirin (RBV) and, recently, in interferon-free combination.

The objective of chronic hepatitis C treatment is to achieve SVR which is defined as the absence of viral replication at 12 or 24 weeks after treatment completion. SVR reduces morbidity and mortality and is equivalent in most cases to cure the HCV infection. Studies have demonstrated that SVR is associated with histological improvement, assessed by liver biopsy, and with the prevention of complications, such as the development of liver cirrhosis and HCC.

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2021-12-24
• Study First Submitted QC: 2021-12-27
• Study First Posted: 2021-12-28
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-29
• Last Update Posted: 2022-06-30
• Primary Completion: 2023-01-01
• Study Completion: 2023-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Chronic HCV patients with moderate to severe hepatic fibrosis (F2: F4) or cirrhosis who received direct-acting antivirals and achieved SVR.

Exclusion Criteria

• Other liver diseases as Chronic hepatitis B and autoimmune liver disease. HIV co-infection.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
changes in hepatic fibrosis	4 years after end of treatment	Shear wave elastography

Secondary Outcome Measures

Name	Time	Method
change in bilirubin level	4 years after end of treatment	change in liver function
change in serum albumin level	4 years after end of treatment	change in liver function
change in prothrombin level	4 years after end of treatment	change in liver function

Trial Locations

Locations (1)

Sohag University Hospital; 🇪🇬 Sohag, Egypt