Long Term Follow up of Chronic HCV Patients Receiving DAAS

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05170490

Enrollment

100

Registered

2021-12-28

Start date

2018-06-01

Completion date

2023-03-01

Last updated

2022-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis c

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
changes in hepatic fibrosis	4 years after end of treatment	Shear wave elastography

Secondary

Measure	Time frame	Description
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
change in bilirubin level	4 years after end of treatment	change in liver function

Countries

Egypt

Contacts

Primary ContactAmira Maher, MD

amiramaher@med.sohag.edu.eg00201006789652

Outcome results