Long Term Follow up of Chronic HCV Patients Receiving DAAS

NCT ID: NCT05170490

Last Updated: 2022-06-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2023-03-01

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.

Conditions

Chronic Hepatitis c

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Amira Maher

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag University Hospital

Sohag, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Amira Maher, MD

Role: CONTACT

amiramaher@med.sohag.edu.eg

00201006789652

Facility Contacts

Amira Maher, MD

Role: primary

amiramaher@med.edu.sohag.eg

00201006789652

Other Identifiers

DAAS in HCV patients

Identifier Type: -

Identifier Source: org_study_id