Study to Determine the Hepatitis C Virus Infection Prevalence Among Patients Attended Primarily for Vasculitis

NCT03693586 | Completed DMC

• 1 other identifier: DI/18/107/03/071
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic hepatitis C infection (CHC) is usually asymptomatic; nevertheless, there are studies that show that up to two thirds of patients may present some type of extrahepatic manifestation. The most frequent extrahepatic manifestation is type II mixed cryoglobulinemia (MCG-II) and clinically the most common presentation is leukocytoclastic vasculitis (LCV) with palpable purpura that affects the lower extremities. It is estimated that up to 80% of MCG-II cases are due to CHC. Also, previous studies have demonstrated that CHC prevalence is higher in patients with autoimmune diseases compared with general population. Therefore, if vasculitis is an extrahepatic manifestation of CHC, then the prevalence of CHC infection in this group of patients could be higher than the prevalence reported in general population. The aim of the study is to know the prevalence of CHC, determined by serological rapid test for hepatitis C screening, then all positive cases will be confirmed by quantitative viral load, in patients who consult primarily to a rheumatology department for "vasculitis" or other potential hepatitis C extrahepatic manifestations (rheumatological conditions).

Conditions

Chronic Hepatitis c; Vasculitis

Keywords

seroprevalence; viral load; chronic hepatitis c; vasculitis

Outcome Measures

Primary Outcomes (1)

• seropositive for hepatitis C

  serological rapid test screening for hepatitis C

  1 year

Secondary Outcomes (1)

• confirmation of a hepatitis C case

  1 year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who primarily consults to a rheumatology department for vasculitis and agree to be evaluated through a questionaire to identificate risk factors for hepatitis C and who also agree to be screened with a serological rapid test for hepatitis C

You may qualify if:

• patients who primarily consults to a rheumatology department for vasculitis and agree to be evaluated through a questionaire to identify risk factors for hepatitis C and who also agree to be screened with a serological rapid test for hepatitis C.

You may not qualify if:

• patients who decline to participate

Sponsors & Collaborators

• Hospital General de Mexico: lead
• AbbVie: collaborator

Study Sites (1)

Hospital General de Mexico

Mexico City, 06726, Mexico

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Vasculitis

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• FATIMA HIGUERA-DE LA TIJERA, MSc.

  Hospital General de México

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Gastroenterology and Hepatology Department

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: October 3, 2018
• Study Start: October 19, 2018
• Primary Completion: March 8, 2022
• Study Completion: March 8, 2022
• Last Updated: March 17, 2022

Record last verified: 2022-03

Locations

ME (1)