Prevalence of Hepatitis c Virus Infection Among Rheumatol... | NCT03587714

Studies
Prevalence of Hepatitis c Virus Infection Among Rheumatological Patients

NCT03587714

Sponsor

Assiut University

Status

Completed

Last Update Posted

Jul 16, 2018Actual

Enrollment

800Actual

Phase

Not provided

Conditions

Hepatitis C

Interventions

HCV RT-PCR

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Dec 1, 2017Actual

Completion Date

Mar 1, 2018Actual

First Submitted Date

Jul 4, 2018

First Submission Date that Met QC Criteria

Jul 4, 2018

First Posted Date

Jul 16, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2018

Last Update Posted Date

Jul 16, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Manal Hassanien, principle investigaror, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This study aims at detecting the prevalence of subclinical HCV infection in different rheumatologic disease groups in Egypt.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

800Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HCV RT-PCR	Diagnostic Test	HCV ribonucleic acid by reverse transcriptase polymerase chain reaction (RT-PCR)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HCV RT-PCR	positive	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

pregnancy and end organ failure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Manal Hassanien, MD	Assiut University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut governorate		Asyut			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

3 months

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006526	Hepatitis C

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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)