NCT03587714

Brief Summary

Egypt has the highest prevalence of hepatitis C virus (HCV) in the world. In 2015, the prevalence of HCV RNA was found to be 7.0%.(1) The prevalence of HCV was studied in Rheumatoid arthritis in few studies(2,3), but to our knowledge, no previous work studied it in other rheumatologic diseases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 16, 2018

Completed
Last Updated

July 16, 2018

Status Verified

July 1, 2018

Enrollment Period

11 months

First QC Date

July 4, 2018

Last Update Submit

July 4, 2018

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • HCV RT-PCR

    positive

    3 months

Interventions

HCV RT-PCRDIAGNOSTIC_TEST

HCV ribonucleic acid by reverse transcriptase polymerase chain reaction (RT-PCR)

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All rheumatologic and other muscloskeletal diseased patients attending Rheumatology clinic Assuit university hospital

You may qualify if:

  • Consecutive patients with different rheumatologic diseases from seven- geographically different- rheumatology departments were prospectively studied. None of the patients was known to have previous HCV infection

You may not qualify if:

  • pregnancy and end organ failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut governorate

Asyut, Egypt

Location

Biospecimen

Retention: SAMPLES WITH DNA

Patients' serum samples were screened for the presence of anti-HCV antibodies. All Patients were further evaluated for the presence of HCV ribonucleic acid by reverse transcriptase polymerase chain reaction (RT-PCR)

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Manal Hassanien, MD

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigaror

Study Record Dates

First Submitted

July 4, 2018

First Posted

July 16, 2018

Study Start

January 1, 2017

Primary Completion

December 1, 2017

Study Completion

March 1, 2018

Last Updated

July 16, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will share

detecting the prevalence of subclinical HCV infection in different rheumatologic disease groups in Egypt

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
3 months

Locations

EG(1)