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Epidemiology of Hepatitis B, C and Delta in Reunion Island (HEPEPID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03362866
Recruitment Status : Not yet recruiting
First Posted : December 5, 2017
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de la Réunion

Study Description
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Brief Summary:
Viral hepatitis B, C and Δ represent a global public health problem for which France was very early mobilized. Despite this, in its foreword, the Dhumeaux report on "Management of people infected with hepatitis B or hepatitis C viruses" identifies a residual area of weakness in this care that is the incomplete regional epidemiological data in the Overseas Territories. The specific ethno-socio-cultural characteristics of these territories make it difficult to transpose data from the mainland France. This study aims at improving our knowledge on the characteristics of patients with hepatitis B, C and Δ in Reunion Island, their follow-up, their evolution and complications.

Condition or disease
Hepatitis B Hepatitis C Hepatitis D

Study Design
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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiology of Hepatitis B, C and Delta in Reunion Island
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with hepatitis B, C and Δ in Reunion [ Time Frame: Up to 5 years ]
    Hepatitis diagnosis will be made according to the ongoing guidelines in France (referred by the National AIDS and Hepatitis Research Agency (ANRS)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Hepatitis B, C, D patients in Reunion Island
Criteria

Inclusion Criteria:

Major patient

  • with confirmed HBsAg and / or anti HCV positive Ab
  • residing in Reunion Island
  • followed in one of the participating centers

Exclusion Criteria:

• Patient carrying isolated anti HBc antibodies

Contacts and Locations
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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): NCT03362866


Contacts
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Contact: Olivier Maillard, PharmD +262693025589 olmaillard@yahoo.fr

Sponsors and Collaborators
Centre Hospitalier Universitaire de la Réunion
More Information
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Responsible Party: Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier: NCT03362866    
Other Study ID Numbers: 2016/CHU/14
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis B
Hepatitis D
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus Infections