CClinicalTrials.gg
Status unknownNCT05170490Updated Jun 30, 2022

Long Term Follow up of Chronic HCV Patients Receiving DAAS

An observational study in Chronic Hepatitis c, sponsored by Sohag University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-30.

Sponsored by Sohag University · Observational

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

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In context

Hepatitis C

2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.

This study's planned enrollment of 100 is below the median of 244 across 567 observational studies indexed under Hepatitis C.

Browse Hepatitis C studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

adult patients with chronic hepatitis C who received direct-acting antiviral drugs and scheived SVR

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
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What researchers measure

Primary outcomes

  1. changes in hepatic fibrosis

    Shear wave elastography

    Time frame: 4 years after end of treatment

Secondary outcomes

  1. change in serum albumin level

    change in liver function

    Time frame: 4 years after end of treatment

  2. change in prothrombin level

    change in liver function

    Time frame: 4 years after end of treatment

  3. change in bilirubin level

    change in liver function

    Time frame: 4 years after end of treatment

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05170490
Lead sponsor
Sohag University
Responsible party
Amira Maher (Lecturer, Sohag University) — Principal investigator
First posted
Dec 28, 2021
Start date
Jun 1, 2018
Primary completion
Jan 1, 2023 (estimated)
Completion
Mar 1, 2023 (estimated)
Last update
Jun 30, 2022

Study contacts

Amira Maher, MD
Contact
amiramaher@med.sohag.edu.eg
00201006789652

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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