Long Term Follow up of Chronic HCV Patients Receiving DAAS

Chronic Hepatitis c Clinical Trial

Official title:

Long Term Follow up of Chronic Hepatitis C Patients Treated With Direct Acting Antivirals After Sustained Virological Response

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05170490
• Other study ID #: DAAS in HCV patients
• Status: Recruiting
• Start date: June 1, 2018
• Est. completion date: March 1, 2023

Study information

• Verified date: June 2022
• Source: Sohag University
• Contact: Amira Maher, MD
• Phone: 00201006789652
• Email: amiramaher[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis c
• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
Egypt	Sohag University Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in hepatic fibrosis	Shear wave elastography	4 years after end of treatment
Secondary	change in serum albumin level	change in liver function	4 years after end of treatment
Secondary	change in prothrombin level	change in liver function	4 years after end of treatment
Secondary	change in bilirubin level	change in liver function	4 years after end of treatment