NCT05170490

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

December 24, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 28, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

4.6 years

First QC Date

December 24, 2021

Last Update Submit

June 29, 2022

Conditions

Chronic Hepatitis c

Outcome Measures

Primary Outcomes (1)

  • changes in hepatic fibrosis

    Shear wave elastography

    4 years after end of treatment

Secondary Outcomes (3)

  • change in serum albumin level

    4 years after end of treatment

  • change in prothrombin level

    4 years after end of treatment

  • change in bilirubin level

    4 years after end of treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Amira Maher, MD

CONTACT

00201006789652amiramaher@med.sohag.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

December 24, 2021

First Posted

December 28, 2021

Study Start

June 1, 2018

Primary Completion

January 1, 2023

Study Completion

March 1, 2023

Last Updated

June 30, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)