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

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ClinicalTrials.gov Identifier: NCT03693586
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : August 12, 2019
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
MARIA DE FATIMA HIGUERA DE LA TIJERA, Hospital General de Mexico

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).


Condition or disease
Chronic Hepatitis c Vasculitis

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Study to Determine the Hepatitis C Virus Infection Prevalence Among Patients Attended Primarily for Vasculitis and Other Potential Extrahepatic Manifestations
Actual Study Start Date : October 19, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. seropositive for hepatitis C [ Time Frame: 1 year ]
    serological rapid test screening for hepatitis C


Secondary Outcome Measures :
  1. confirmation of a hepatitis C case [ Time Frame: 1 year ]
    viral load and genotypification



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • patients who decline to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03693586


Contacts
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Contact: FATIMA G HIGUERA-DE LA TIJERA, MSc. +52(55)27892000 ext +7, 0047 fatimahiguera@hotmail.com

Locations
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Mexico
Hospital General de Mexico Recruiting
Mexico City, Mexico, 06726
Contact: FATIMA HIGUERA-DE LA TIJERA, MD. MSc    +52(55)27892000 ext +7,0047    fatimahiguera@hotmail.com   
Sub-Investigator: Karla A Soto Hernández, MD         
Sub-Investigator: Nidia Uribe, MD         
Sub-Investigator: Alfredo Servín Caamaño, MD         
Sub-Investigator: Conrado García García, PhD         
Sub-Investigator: Everardo Alvarez Hernández, PhD         
Sub-Investigator: José L Pérez Hernández, MSc         
Sponsors and Collaborators
Hospital General de Mexico
AbbVie
Investigators
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Principal Investigator: FATIMA HIGUERA-DE LA TIJERA, MSc. Hospital General de México

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Responsible Party: MARIA DE FATIMA HIGUERA DE LA TIJERA, Head of Gastroenterology and Hepatology Department, Hospital General de Mexico
ClinicalTrials.gov Identifier: NCT03693586     History of Changes
Other Study ID Numbers: DI/18/107/03/071
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MARIA DE FATIMA HIGUERA DE LA TIJERA, Hospital General de Mexico:
seroprevalence
viral load
chronic hepatitis c
vasculitis
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Vasculitis
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Vascular Diseases
Cardiovascular Diseases